Photobiomodulation Therapy Garment, Methods and Uses

ABSTRACT

The present specification discloses a photobiomodulation therapy garment having a garment structure configured to be donned by a user atop a skin surface with one or more near-infrared light sources integrated with the garment structure. The near-infrared light source is configured to emit near-infrared light directed to one or more regions of interest of the skin at a wavelength between 600 nm to 1600 nm and at a predetermined dosimetry and duration. A controller with a processor and memory is in communication near-infrared light source to control the operational parameters of the near-infrared light source.

This application is a 35 U.S.C. § 111 patent application that claims thebenefit of priority and is entitled to the filing date pursuant to 35U.S.C. § 119(e) of U.S. Provisional Patent Application 63/272,363, filedOct. 27, 2021 and U.S. Provisional Patent Application 63/172,405, filedApr. 8, 2021, the content of each of which is hereby incorporated byreference in its entirety.

BACKGROUND

The subject of this patent application relates generally to devices andmethods for treating disorders using photobiomodulation therapy withnear-infrared light.

By way of background, photobiomodulation therapy is the application ofnear-infrared light directed to various portions of a subject's body,for example, to the skin. Photobiomodulation therapy induces aphotochemical reaction in the cells, increasing mitochondrial activityand ATP levels. The near-infrared light is calibrated to penetratethrough the skin, soft tissue, cartilage, cerebrospinal fluid, andthrough bone structure for the purpose of providing treatment forvarious disorders. In an example transcranial photobiomodulationtreatment, a near-infrared light source is directed to the head, suchthat the near-infrared light penetrates the skull to apply the light tothe brain, for treating mental health related conditions like stress,fatigue, ADHD, other psychiatric, neuropsychiatric, andneurodegenerative diseases, and so on.

During treatment, one or more light source must be held in position onthe user's skin for a prolonged period of time. However, the user maywish to continue with daily activities during the treatment period,requiring a portable system that remains in place during sedentary andvigorous activities, so that treatment is delivered accurately andwithout disturbance. Furthermore, a portable system would allow fromimmediate, real-time use enabling the user to undergo aphotobiomodulation therapy whenever needed.

Aspects of the present invention fulfill these needs and provide furtherrelated advantages as described in the following summary.

SUMMARY

Aspects of the present invention teach certain benefits in constructionand use which give rise to the exemplary advantages described below.

The present specification discloses a photobiomodulation therapy garmenthaving a garment configured to be donned by a user atop a skin surfacewith one or more near-infrared light sources integrated with thegarment. The near-infrared light source is configured to emitnear-infrared light directed to one or more regions of interest of theskin at a wavelength between about 700 nm to about 1600 nm and at apredetermined dosimetry and duration. A controller with a processor andmemory is in communication near-infrared light source to control theoperational parameters of the near-infrared light source.

Other features and advantages of aspects of the present invention willbecome apparent from the following more detailed description, taken inconjunction with the accompanying drawings, which illustrate, by way ofexample, the principles of aspects of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate aspects of the disclosed subjectmatter in at least one of its exemplary embodiments, which are furtherdefined in detail in the following description. Features, elements, andaspects of the disclosure are referenced by numerals with like numeralsin different drawings representing the same, equivalent, or similarfeatures, elements, or aspects, in accordance with one or moreembodiments. The drawings are not necessarily to scale, emphasis insteadbeing placed upon illustrating the principles herein described andprovided by exemplary embodiments of the invention. In such drawings:

FIG. 1 is a front perspective view of an exemplary photobiomodulationtherapy garment disclosed herein donned by a user;

FIG. 2 is a rear plan view of an exemplary photobiomodulation therapygarment in an open configuration;

FIG. 3 is a magnified rear plan view of the photobiomodulation therapygarment of FIG. 2, illustrating an exemplary intergroup and intragrouparrangement of near-infrared light sources;

FIG. 4 is a rear perspective view of the photobiomodulation therapygarment of FIG. 2;

FIG. 5 is a front perspective view of the photobiomodulation therapygarment of FIG. 2, illustrating the terminal rail with controllerdetached;

FIG. 6 is a front perspective view of the photobiomodulation therapygarment of FIG. 2, illustrating a controller disclosed herein fastenedto the photobiomodulation therapy garment;

FIG. 7 is a front perspective view of the photobiomodulation therapygarment of FIG. 6 in a closed configuration, illustrating the adjustmentstrap closed to form a band;

FIG. 8 is an exploded perspective view of the photobiomodulation therapygarment of FIG. 5;

FIG. 9 is a top plan view of a photobiomodulation unit disclosed hereincomprising a flexible printed circuit board assembly;

FIG. 10 is a magnified cross-sectional view of photobiomodulation unitof FIG. 9, taken at 10-10, illustrating a sensor disclosed herein;

FIG. 11 is a top plan view of a photobiomodulation unit disclosed hereincomprising a flexible printed circuit board assembly;

FIG. 12 is a top plan view of a photobiomodulation unit disclosed hereincomprising a flexible printed circuit board assembly;

FIG. 13 is a top plan view of a photobiomodulation unit disclosed hereincomprising a flexible printed circuit board assembly;

FIG. 14 is a top plan view of a photobiomodulation unit disclosed hereincomprising a flexible printed circuit board assembly;

FIG. 15 is an exploded rear perspective view of the photobiomodulationtherapy garment disclosed herein, illustrating a liquid wire circuitassembly; and

FIG. 16 is an exploded rear perspective view of the photobiomodulationtherapy garment disclosed herein, illustrating a liquid wire circuitassembly;

FIGS. 17A-17C show EEG scans of five participants from a research studywho underwent a transcranial photobiomodulation (tPBM) treatment using aphotobiomodulation therapy garment disclosed herein with FIG. 17Ashowing an EEG scan of each participant before a tPBM treatment; FIG.17B showing an EEG scan of each participant after a tPBM treatment; andFIG. 17C showing merged before and after EEG scans to highlight thedifference; and

FIGS. 18A-18B show graphs of data obtained from an EEG scan of aparticipant using a photobiomodulation therapy garment disclosed hereinwith FIG. 18A showing percent change of frequency during use of aphotobiomodulation therapy garment disclosed herein; and FIG. 18Bshowing change in gamma power over time during use of aphotobiomodulation therapy garment disclosed herein.

Listing of Reference Numbers Associated with Drawings Ref. No. Element PPerson S Skin surface H Head region d1 Column intergroup spacing d2 Rowintergroup spacing d3 Column intragroup spacing d4 Row intragroupspacing 20 Photobiomodulation therapy garment 22 Photobiomodulationtherapy headband 30 Garment of photobiomodulation therapy garment 20, 2240 Outer fabric sheet of garment 24 42 Outside surface of outer fabricsheet 40 44 Inside surface of outer fabric sheet 40 46 Therapeuticportion of outer fabric sheet 40 50 Top edge of garment 30 52 Bottomedge of garment 30 54 Right portion of garment 30 56 Left portion ofgarment 30 58 Terminal rail mount opening of garment 30 60 Slide buckleof garment 30 62 Slide buckle of garment 30 64 Right head strap ofgarment 30 66 Left head strap of garment 30 68 Controller strap ofgarment 30 70 Inner fabric sheet of garment 24 72 Outside surface ofinner fabric sheet 70 74 Inside surface of inner fabric sheet 70 76Near-infrared light opening of inner fabric sheet 70 78 Sensor openingof inner fabric sheet 70 79 Sensor cover of inner fabric sheet 70 100Photobiomodulation unit of photobiomodulation therapy garment 20, 22 102Heat dissipating material of photobiomodulation 100 110 Flexible printedcircuit board assembly of photobiomodulation 100 112 Main strip offlexible printed circuit board assembly 110 113 Root of flexible printedcircuit board assembly 110 114 First strip of flexible printed circuitboard assembly 110 116 Second strip of flexible printed circuit boardassembly 110 117 Connecting portion of flexible printed circuit boardassembly 110 118 Sensor strip cutout of flexible printed circuit boardassembly 110 120 First mounting portion of first strip 114 121 Firstcutout of first strip 114 122 Second mounting portion of first strip 114123 Second cutout of first strip 114 124 Third mounting portion of firststrip 114 130 First mounting portion of second strip 116 131 Firstcutout of second strip 116 132 Second mounting portion of second strip116 133 Second cutout of second strip 116 134 Third mounting portion ofsecond strip 116 140 Sensor strip of flexible printed circuit boardassembly 110 142 Sensor mounting portion of sensor strip 140 144 Sensorstrip free end of sensor strip 140 150 Liquid wire circuit assembly ofphotobiomodulation 100 152 Main liquid wire tube of liquid wire circuitboard assembly 150 153 Root of liquid wire circuit board assembly 150154 First liquid wire tube of liquid wire circuit board assembly 150 156Second liquid wire tube of liquid wire circuit board assembly 150 158Sensor liquid wire tube of liquid wire circuit board assembly 150 160Connection terminal of circuit board assembly 84 162 Electronic circuityconnector of connection terminal 160 164 Terminal rail mount ofconnection terminal 160 166 Contacts of terminal rail mount 164 170Near-infrared light source of photobiomodulation 100 171 Firstnear-infrared light source grouping of near-infrared light source 170172 Second near-infrared light source grouping of near-infrared lightsource 170 173 Third near-infrared light source grouping ofnear-infrared light source 170 174 Fourth near-infrared light sourcegrouping of near-infrared light source 170 175 Fifth near-infrared lightsource grouping of near-infrared light source 170 176 Sixthnear-infrared light source grouping of near-infrared light source 170180 Sensor of photobiomodulation unit 100 182 Cardiovascular sensor ofphotobiomodulation 100 184 Green LED of cardiovascular sensor 182 186Green LED of cardiovascular sensor 182 188 Photodetector ofcardiovascular sensor 182or 114 192 Temperature sensor ofphotobiomodulation 100 194 Stimulator of photobiomodulation unit 100 200Controller of photobiomodulation therapy garment 20, 22 210 Hot meltadhesive film of photobiomodulation therapy garment 20, 22 220Double-sided tape layer of photobiomodulation therapy garment 20, 22 222Near-infrared light source opening of double-sided tape layer 220 224Sensor opening of double-sided tape layer 220 300 Fp1 site of person P302 Fpz site of person P 304 Fp2 site of person P 306 F3 site of personP 308 Fz site of person P 310 F4 site of person P 320 Sagittal plane ofperson P 322 Superciliary arch region of person P

DETAILED DESCRIPTION

The detailed descriptions set forth below in connection with theappended drawings are intended as a description of embodiments of theinvention, and is not intended to represent the only forms in which thepresent invention may be constructed and/or utilized. The descriptionsset forth the structure and the sequence of steps for constructing andoperating the invention in connection with the illustrated embodiments.It is to be understood, however, that the same or equivalent structuresand steps may be accomplished by different embodiments that are alsointended to be encompassed within the spirit and scope of the invention.

The present system in one or more embodiments provides aphotobiomodulation therapy garment. A photobiomodulation therapy garmentdisclosed herein comprising a garment configured to be donned by a useratop a skin surface which integrates one or more photobiomodulationunits which in conjunction with a controller are configured toadminister a photobiomodulation therapy. A photobiomodulation unitincludes one or more near-infrared light sources, one or more sensors,and optionally one or more stimulators in electrical connection with aconnection terminal. The connection terminal is also configured tooperationally receive the controller in an manner that establishes anelectrical connection. Each of the one or more near-infrared lightsources disclosed herein is configured to emit near-infrared light at awavelength between 600 nm to 1600 nm and at a predetermined dosimetryand duration. A controller disclosed herein has a processor and memoryand is configured to control the operational parameters of thenear-infrared light source. During operation, a photobiomodulation unitis configured to emit near-infrared light to one or more regions of askin surface of a user. In some embodiments, and as shown in FIGS. 1-16,a photobiomodulation therapy garment 20 comprises a garment 30, aphotobiomodulation unit 100, and a controller 200.

In some embodiments, and as shown in FIGS. 1-7, photobiomodulationtherapy garment 20 can be configured as a photobiomodulation therapyheadband 22 for the purpose of treating specific regions of a head H ofa person P using a transcranial photobiomodulation therapy. In thisconfiguration, person P dons photobiomodulation therapy headband 22 bywrapping snugly around head region H so that one or more near-infraredlight sources disclosed herein integrated into photobiomodulationtherapy headband 22 are positioned overtop and/or directed to a regionof interest of skin surface S for delivering therapeutic levels ofnear-infrared light to a region of interest. In some embodiments,positioning of phtobiomodulation therapy headband 22 as shown in FIG. 1,situates the one or more near-infrared light sources disclosed hereinatop a frontal bone region of the skull of person P, approximatelyand/or substantially centered on midsagittal plane 320 (e.g., centeredon the nose) for the purpose of administering near-infrared light fortreating a disorder through the skull to a brain region of person P.Further, in these embodiments, photobiomodulation therapy headband 22 ispositioned such that one the near-infrared light sources disclosedherein are approximately positioned above superciliary arch region 322(i.e., the brown ridge above the eye sockets); and generally beneath thehairline (although the hairline varies somewhat depending on theindividual). At minimum, in one or more embodiments, at least one thenear-infrared light sources disclosed herein integrated withinphotobiomodulation therapy headband 22 should be positioned abovesuperciliary arch region 322 or at minimum above the eye sockets, tominimize exposure of the eyes to the near-infrared light. In someembodiments, and as shown in FIG. 1, photobiomodulation therapy headband22 is positioned to cover defined regions of interest on skin surface Scomprising one or more or all of a Fp1 site 300, a Fpz site 302, a Fp2site 304, a F3 site 306, a Fz site 308, and a F4 site 310, whenphotobiomodulation therapy headband 22 is donned on head H and properlypositioned.

Although, photobiomodulation therapy garment 20 is illustrated asphotobiomodulation therapy headband 22 in FIGS. 1-16, aphotobiomodulation therapy garment disclosed herein can be constructedto be donned on a variety of body portions. In some embodiments, aphotobiomodulation therapy garment disclosed herein can be configured towrap about or conform to a wide variety of body parts, with thecapability to be moved from one region of interest to another region ofinterest on the body. In some embodiments, a photobiomodulation therapygarment disclosed herein can be configured specifically to fit aparticular body part, such as, e.g., as a head covering, a visor, a neckwrap, a shoulder wrap, a wrist wrap, or an abdominal wrap. In someembodiments, a photobiomodulation therapy garment disclosed herein canbe configured to be fitted to a wide variety of body parts of anindividual, with the capability to be worn by the individual, such as,e.g., a hat, a shirt, a pants, or an undergarment.

A photobiomodulation therapy garment 20 comprises a garment. Garment canbe made flexible, semirigid, or rigid and is constructed to becomfortable to the user's body and configured to behave much like anitem of clothing or other donned fashion accessory. In some embodiments,a garment disclosed herein is a fabric material made through weaving,knitting, spreading, felting, stitching, crocheting or bonding. In someembodiments, garment is composed of multiple layers of fabric material.For example, in some embodiments, photobiomodulation therapy garmentcomprises an outer fabric sheet and an inner fabric sheet. Outer fabricsheet is sized and dimensioned to serve as base for mounting one or morephotobiomodulation units and a controller disclosed herein whereas innerfabric assembly is sized and dimensioned to at least cover the one ormore photobiomodulation units.

For example, in some embodiments, and referring to FIGS. 2-4, & 7, 8,15, & 16 photobiomodulation therapy headband 22 comprises garment 30including an outer fabric sheet 40 and an inner fabric sheet 70 and aphotobiomodulation unit 100 sandwiched between outer fabric sheet 40 andinner fabric sheet 70. Outer fabric sheet 40 can be made of a widevariety of natural or synthetic textiles, generally chosen for aestheticand/or protective qualities. Inner fabric sheet 70 is configured to lieagainst skin surface S, and can be made of natural or synthetic textileor other material which is comfortable against skin surface S, such asspace cotton or the like. As shown in FIGS. 2-7, top and bottom portionsof outer fabric sheet 40 and inner fabric sheet 70 are affixed to oneanother to form a top edge 50 and a bottom edge 52 of garment 30 in amanner that encloses photobiomodulation unit 100 therewithin.

As shown in FIGS. 2, 4-6, 8, 15, & 16 outer fabric sheet 40 of garment30 also comprises a right head strap 64 extends longitudinally from theright portion 54 of garment 30 and a left head strap 66 extendslongitudinally from left portion 56 of garment 30. Slide buckle 60permits length adjustment of right head strap 64 and slide buckle 62 isconnected to right head strap 64 and held to right head strap 64 via aloop created by slide buckle 60. Slide buckle 62 is configured toreceive the free end of left head strap 66, where left head strap 66 caninclude hook and loop mating portions to complete the connection. Thishead strap arrangement permits easy adjustment of photobiomodulationtherapy headband 22 and secure attachment to head H.

As shown in FIG. 8, outer fabric sheet 40 of garment 30 comprises aterminal rail mount opening 58 sized and dimensioned to receive aterminal rail of a connection terminal disclosed herein in a manner thatenables proper engagement of controller 200 to the terminal rail.Referring to FIGS. 2, 4-6, 8, 15, & 16, outer fabric sheet 40 of garment30 also comprises controller strap 68 extends from a left portion 56 ofgarment 30. Controller strap 68 is configured to be wrapped aboutcontroller 200 once controller 200 is operationally engaged tophotobiomodulation unit 100 in order to securely hold controller 200against outer fabric sheet 40. Controller strap 68 has a first endsecurely affixed to garment 30 and the second end opposite the first endthat can loop around attached controller 200 thereby reversibly securingcontroller 200 to garment 30 using, e.g., a hook and loop fastener, abuckle or snaps. Controller strap 68 can be composed of a non-elastic orelastic material.

As best seen in FIGS. 8, 15 & 16, inner fabric sheet 70 of garment 30comprises one or more near infrared light source openings 76 and one ormore sensor openings 78. Each of the one or more near infrared lightsource openings 76 is a cutout positioned on inner fabric sheet 70 sothat when assembled each opening 76 is aligned with an infrared lightsource disclosed herein in a manner that permits light from the infraredlight source to emit through the infrared light source opening 76.Similarly, each of the one or more sensor openings 78 is a cutoutpositioned on inner fabric sheet 70 so that when assembled each opening78 is aligned with a sensor disclosed herein in a manner that permitsthe sensor to properly function and collect information from a userthrough the sensor opening 78.

In some embodiments, and referring to FIGS. 2-4 & 8, inner fabric sheet70 can include one or more sensor covers 79. Each sensor cover 79 isposition over and protects each of the one or more sensors disclosedherein mounted on photobiomodulation unit 100. In addition, each of theone or more sensor covers 79 is configured to be in contact or is placedin close proximity to skin surface S when photobiomodulation therapygarment 20 is donned. Each sensor cover 79 can be attached to innerfabric sheet 70, or photobiomodulation unit 100, and/or sandwichedtherebetween. Each sensor cover 79 is constructed of a thin sheet of PVCin this example embodiment, which permits the one or more sensorslocated thereunder to interact with skin surface S to measure bodilyfunctions, such as one or more of a temperature, a heart rate, a bloodoxygen level, and other measurable functions. Further, each sensor cover79 provides a visible reference to assist a user in properly orientatingand donning photobiomodulation therapy garment 20. For example, whenplacing photobiomodulation therapy headband 22 about head H, the one ormore sensor covers 79 can be manually aligned with the nose, placingsensor cover 79 substantially on top of sagittal plane 320.

A photobiomodulation therapy garment 20 also includes aphotobiomodulation unit. A photobiomodulation unit includes a connectionterminal, one or more near-infrared light sources, one or more sensorsand is configured to establish electronic communication with controller200. In some embodiments, and referring to FIGS. 8, 9 & 11, aphotobiomodulation unit 100 comprises a flexible printed circuit boardassembly 110 that provides a flexible substrate housing the electricalcircuitry which establishes electronic communication between aconnection terminal 160 and one or more near-infrared light sources 170,such as, e.g., an infrared light, low-level laser, and/or light emitteddiode (LED), one or more sensors 180, and optionally one or morestimulators 194. Connection terminal 160 (generally rigid or semirigid)includes an electronic circuitry connector 162 mounted thereon, whereelectronic circuitry connector 162 is configured to provide electroniccommunication between controller 200 and flexible printed circuit boardassembly 110. In these embodiments, flexible printed circuit boardassembly 110 is configured to provide flexibility and comfort to thewearer. For example, since photobiomodulation therapy headband 22 mustclosely match the contours of the forehead, flexible printed circuitboard assembly 110 is designed with strategic cutouts to permit maximumflexibility and comfort. In some embodiments, and as shown in FIGS. 8 &10, flexible printed circuit board assembly 110 comprises aheat-dissipating material 102 on the flexible substrate on the sideopposite the electrical circuitry that dispels heat generating byflexible printed circuit board assembly 110 during operation ofphotobiomodulation therapy garment 20.

In some embodiments, and referring to FIGS. 9 & 11, flexible printedcircuit board assembly 110 is a thin, flat substrate that includes afirst surface and a second surface opposite the first surface and isconfigured as a main strip 112 which extends from connection terminal160 and trifurcates at a root 113 into a first strip 114, a second strip116, and a sensor strip 140 extending from the middle. First strip 114and second strip 116 are connected distally by a connecting portion 117and all define the bounds of cutout 118. First strip 114 and secondstrip 116 contain the electronic circuitry needed to establishelectronic communication between each near-infrared light source 170operationally mounted on first strip 114 or second strip 116 andconnection terminal 160.

In some embodiments, first strip 114 and second strip 116 each include aseries of tabs laterally extending outward therefrom, for mountingthereon near-infrared light sources disclosed herein. For example, asshown in FIGS. 9 & 11, first strip 114 includes a first mounting portion120, a second mounting portion 122, and a third mounting portion 124,with first mounting portion 120 separated from second mounting portion122 by a first cutout 121 therebetween, and third mounting portion 124separated from second mounting portion 122 by a second cutout 123therebetween. Similarly, second strip 116 includes a first mountingportion 130, a second mounting portion 132, and a third mounting portion134, with first mounting portion 130 separated from second mountingportion 132 by a first cutout 131 therebetween, and third mountingportion 134 separated from second mounting portion 132 by a secondcutout 133 therebetween. First, second, third, mounting portions 120,122, 124 of first strip 114 and first, second, third, mounting portions130, 132, 134 of second strip 116 act like gores to permit independentflexible bending of flexible printed circuit board assembly 110. Suchflexible bending enables flexible printed circuit board assembly 110 toeasily conform to the contours of one or more regions of interest ofskin region S and places each of the one or more near-infrared lightsources disclosed herein in close proximity to skin surface S withminimal or no gap.

In some embodiments, and referring to FIGS. 9 & 11, sensor strip 140includes a sensor mounting portion 142 and a free end 144. Sensor strip140 extends from root 113 into cutout 118 in a manner where cutout 118provides clearance of sensor strip 140 from first strip 114 and secondstrip 116 such that sensor strip 140 is disconnected from first strip114 and second strip 116 except at root 113. Sensor strip 140 containsthe electronic circuitry needed to establish electronic communicationbetween each sensor 180 operationally mounted on sensor strip 140 andconnection terminal 160. Sensor strip 140 is relatively thin andelongated to permit bending and slight movement of sensor strip 140relative to the remainder of flexible printed circuit board assembly110, which is additionally permitted due to a sensor opening 224provided by a double-sided tape 220 (see FIGS. 8, 15, & 16), whichpermits easy bending and fitting about head H, with little or no kinksin flexible printed circuit board assembly 110.

In some embodiments, and referring to FIGS. 5, 8, 9, 11, 15, & 16,integrally mounted to one end of flexible printed circuit board assembly110 is connection terminal 160. Connection terminal 160 compriseselectronic circuitry connector 162 and a terminal rail mount 164.Electronic circuitry connector 162 of connection terminal 160 is locatedon the same surface of flexible printed circuit board assembly 110 whereone or more infrared light sources 170, one or more sensors 180, and oneor more stimulators 194 are mounted and contains the electricalcircuitry used to establish electronic communication with one or moreinfrared light sources 170, one or more sensors 180, and one or morestimulators 194. Terminal rail mount 164 of connection terminal 160 islocated on flexible printed circuit board assembly 110 on the surfaceopposite of electronic circuitry connector 162. Terminal rail mount 164includes a plurality of contacts 166. Terminal rail mount 164 isconfigured to receive controller 200 and establish electroniccommunication between photobiomodulation unit 100 and controller 200which has corresponding contacts that mate with contacts 166 whenconnected. To permit quick connection and disconnection, controller 200and terminal rail mount 164 include sliding joinery (e.g., dovetail ortongue and groove like joinery) to capture controller 200 withinterminal rail mount 164 and force electrical contact between contacts166 of terminal rail mount 164 and corresponding contacts protrudingthough controller 200. After sliding controller 200 into terminal railmount 164, controller strap 68 is wrapped over controller 200 andfastened to inside portion 44 of outer fabric sheet 40 by a releasableconnection, such as hook and loop.

In some embodiments, and referring to FIGS. 15 & 16, photobiomodulationunit 100 comprises a liquid wire circuit assembly 150 that provideselectronic communication between connection terminal 160 and one or morenear-infrared light sources 170, such as, e.g., an infrared light,low-level laser, and/or light emitted diode (LED), one or more sensors180, and optionally one or more stimulators 194. A liquid wire comprisesa type of metal that remains in the liquid phase at room temperaturewhich is enclosed in a flexible tubing. Owing to its liquid phasenature, liquid metal can make good contact with objects in any shape andcan maintain excellent electrical properties upon the deformation of thesubstrate or the covering film. Non-limiting examples of liquid metalinclude gallium and alloys such as eutectic gallium-indium. Liquid wirecircuit assembly 150 includes connection terminal 160 with electroniccircuitry connector 162 mounted thereon, where electronic circuitryconnector 162 is configured to provide electrical communication betweenone or more liquid wire tubes of circuit assembly 150 and connectionterminal 160. In these embodiments, liquid wire circuit assembly 150 isconfigured to provide flexibility and comfort to the wearer. Forexample, since photobiomodulation therapy headband 22 must closely matchthe contours of the forehead, liquid wire circuit assembly 150 isdesigned with strategic cutouts to permit maximum flexibility andcomfort.

In some embodiments, and referring to FIGS. 15 & 16, liquid wire circuitassembly 150 comprises a main liquid wire tube 152 which extends fromconnection terminal 160 and trifurcates at a root 153 into a firstliquid wire tube 154, a second liquid wire tube 156, and a sensor liquidwire tube 158 extending from the middle affixed directly to an innersurface of outer fabric sheet 40. First and second liquid wire tubes154, 156 contain the electronic circuitry needed to establish electricalconnection between each near-infrared light source 170 operationallymounted to first or second liquid wire tubes 154, 156 and connectionterminal 160 which, in turn provides electrical connection to controller200. Sensor liquid wire tube 158 contains the electronic circuitryneeded to establish electrical communication between each sensor 180and/or each stimulator 194 operationally mounted to sensor liquid wiretube 158 and connection terminal 160 which, in turn provides electricalconnection to controller 200. The affixing of first and second liquidwire tubes 154, 156 and sensor liquid wire tube 158 directly to an innersurface of outer fabric sheet 40 enables liquid wire circuit assembly150 to easily conform to the contours of one or more regions of interestof skin region S and places each of the one or more near-infrared lightsources disclosed herein in close proximity to skin surface S withminimal or no gap. Although not shown, liquid wire circuit assembly 150can be configured in an arrangement similar to the arrangements shownfor flexible printed circuit board assembly 110 of FIGS. 12-14.

Referring to FIGS. 9-15, photobiomodulation unit 100 also comprises oneor more near-infrared light source 170 each being configured to emitnear infrared light in a wavelength range of 700 nm to 1600 nm. In someembodiments, near-infrared light source 170 emits light having awavelength of, e.g., about 700 nm, about 750 nm, about 800 nm, about 900nm, about 1000 nm, about 1100 nm, about 1200 nm, about 1.300 nm, about1400 nm, or about 1500 nm. In some embodiments, near-infrared lightsource 170 emits light having a wavelength of, e.g., at least 700 nm, atleast 750 nm, at least 800 nm, at least 850 nm, at least 900 nm, atleast 1000 nm, at least 1100 nm, at least 1200 nm, at least 1.300 nm, atleast 1400 nm, or at least 1500 nm. In some embodiments, near-infraredlight source 170 emits light having a wavelength of, e.g., at most 700nm, at most 750 nm, at most 800 nm, at most 850 nm, at most 900 nm, atmost 1000 nm, at most 1100 nm, at most 1200 nm, at most 1.300 nm, atmost 1400 nm, or at most 1500 nm.

In some embodiments, near-infrared light source 170 emits light having awavelength of, e.g., about 700 nm to about 750 nm, about 700 nm to about800 nm, about 700 nm to about 900 nm, about 700 nm to about 1000 nm,about 700 nm to about 1100 nm, about 700 nm to about 1200 nm, about 700nm to about 1300 nm, about 700 nm to about 1400 nm, about 700 nm toabout 1500 nm, about 750 nm to about 800 nm, about 750 nm to about 850nm, about 750 nm to about 900 nm, about 750 nm to about 1000 nm, about750 nm to about 1100 nm, about 750 nm to about 1200 nm, about 750 nm toabout 1300 nm, about 750 nm to about 1400 nm, about 750 nm to about 1500nm, about 800 nm to about 850 nm, about 800 nm to about 900 nm, about800 nm to about 1000 nm, about 800 nm to about 1100 nm, about 800 nm toabout 1200 nm, about 800 nm to about 1300 nm, about 800 nm to about 1400nm, about 800 nm to about 1500 nm, about 850 nm to about 900 nm, about850 nm to about 1000 nm, about 850 nm to about 1100 nm, about 850 nm toabout 1200 nm, about 850 nm to about 1300 nm, about 850 nm to about 1400nm, about 850 nm to about 1500 nm, about 900 nm to about 1000 nm, about900 nm to about 1100 nm, about 900 nm to about 1200 nm, about 900 nm toabout 1300 nm, about 900 nm to about 1400 nm, about 900 nm to about 1500nm, about 1000 nm to about 1100 nm, about 1000 nm to about 1200 nm,about 1000 nm to about 1300 nm, about 1000 nm to about 1400 nm, about1000 nm to about 1500 nm, about 1100 nm to about 1200 nm, about 1100 nmto about 1300 nm, about 1100 nm to about 1400 nm, about 1100 nm to about1500 nm, about 1200 nm to about 1300 nm, about 1200 nm to about 1400 nm,about 1200 nm to about 1500 nm, about 1300 nm to about 1400 nm, about1300 nm to about 1500 nm, or about 1400 nm to about 1500 nm.

In some embodiments, one or more near-infrared light source 170 are eachconfigured to emit near infrared light in a pulse wave (or frequency)range of about 1 Hz to about 100 Hz. In some embodiments, near-infraredlight source 170 emits light having a pulse wave of, e.g., about 10 Hz,about 20 Hz, about 30 Hz, about 40 Hz, about 50 Hz, about 60 Hz, about70 Hz, about 80 Hz, about 90 Hz, or about 100 Hz. In some embodiments,near-infrared light source 170 emits light having a pulse wave of, e.g.,at least 10 Hz, at least 20 Hz, at least 30 Hz, at least 40 Hz, at least50 Hz, at least 60 Hz, at least 70 Hz, at least 80 Hz, at least 90 Hz,or at least 100 Hz. In some embodiments, near-infrared light source 170emits light having a pulse wave of, e.g., at most 10 Hz, at most 20 Hz,at most 30 Hz, at most 40 Hz, at most 50 Hz, at most 60 Hz, at most 70Hz, at most 80 Hz, at most 90 Hz, or at most 100 Hz. In someembodiments, near-infrared light source 170 emits light having a pulsewave of, e.g., about 10 Hz to about 20 Hz, about 10 Hz to about 30 Hz,about 10 Hz to about 40 Hz, about 10 Hz to about 50 Hz, about 10 Hz toabout 60 Hz, about 10 Hz to about 70 Hz, about 10 Hz to about 80 Hz,about 10 Hz to about 90 Hz, about 10 Hz to about 100 Hz, about 20 Hz toabout 30 Hz, about 20 Hz to about 40 Hz, about 20 Hz to about 50 Hz,about 20 Hz to about 60 Hz, about 20 Hz to about 70 Hz, about 20 Hz toabout 80 Hz, about 20 Hz to about 90 Hz, about 20 Hz to about 100 Hz,about 30 Hz to about 40 Hz, about 30 Hz to about 50 Hz, about 30 Hz toabout 60 Hz, about 30 Hz to about 70 Hz, about 30 Hz to about 80 Hz,about 30 Hz to about 90 Hz, about 30 Hz to about 100 Hz, about 40 Hz toabout 50 Hz, about 40 Hz to about 60 Hz, about 40 Hz to about 70 Hz,about 40 Hz to about 80 Hz, about 40 Hz to about 90 Hz, about 40 Hz toabout 100 Hz, about 50 Hz to about 60 Hz, about 50 Hz to about 70 Hz,about 50 Hz to about 80 Hz, about 50 Hz to about 90 Hz, about 50 Hz toabout 100 Hz, about 60 Hz to about 70 Hz, about 60 Hz to about 80 Hz,about 60 Hz to about 90 Hz, about 60 Hz to about 100 Hz, about 70 Hz toabout 80 Hz, about 70 Hz to about 90 Hz, about 70 Hz to about 100 Hz,about 80 Hz to about 90 Hz, about 80 Hz to about 100 Hz, or about 90 Hzto about 100 Hz.

In some embodiments, one or more near-infrared light source 170 are eachconfigured to emit near infrared light in a pulse wave (or frequency)range of about 100 Hz to about 1000 Hz. In some embodiments,near-infrared light source 170 emits light having a pulse wave of, e.g.,about 100 Hz, about 200 Hz, about 300 Hz, about 400 Hz, about 500 Hz,about 600 Hz, about 700 Hz, about 800 Hz, about 900 Hz, or about 1000Hz. In some embodiments, near-infrared light source 170 emits lighthaving a pulse wave of, e.g., at least 100 Hz, at least 200 Hz, at least300 Hz, at least 400 Hz, at least 500 Hz, at least 600 Hz, at least 700Hz, at least 800 Hz, at least 900 Hz, or at least 1000 Hz. In someembodiments, near-infrared light source 170 emits light having a pulsewave of, e.g., at most 100 Hz, at most 200 Hz, at most 300 Hz, at most400 Hz, at most 500 Hz, at most 600 Hz, at most 700 Hz, at most 800 Hz,at most 900 Hz, or at most 1000 Hz. In some embodiments, near-infraredlight source 170 emits light having a pulse wave of, e.g., about 100 Hzto about 200 Hz, about 100 Hz to about 300 Hz, about 100 Hz to about 400Hz, about 100 Hz to about 500 Hz, about 100 Hz to about 600 Hz, about100 Hz to about 700 Hz, about 100 Hz to about 800 Hz, about 100 Hz toabout 900 Hz, about 100 Hz to about 1000 Hz, about 200 Hz to about 300Hz, about 200 Hz to about 400 Hz, about 200 Hz to about 500 Hz, about200 Hz to about 600 Hz, about 200 Hz to about 700 Hz, about 200 Hz toabout 800 Hz, about 200 Hz to about 900 Hz, about 200 Hz to about 1000Hz, about 300 Hz to about 400 Hz, about 300 Hz to about 500 Hz, about300 Hz to about 600 Hz, about 300 Hz to about 700 Hz, about 300 Hz toabout 800 Hz, about 300 Hz to about 900 Hz, about 300 Hz to about 1000Hz, about 400 Hz to about 500 Hz, about 400 Hz to about 600 Hz, about400 Hz to about 700 Hz, about 400 Hz to about 800 Hz, about 400 Hz toabout 900 Hz, about 400 Hz to about 1000 Hz, about 500 Hz to about 600Hz, about 500 Hz to about 700 Hz, about 500 Hz to about 800 Hz, about500 Hz to about 900 Hz, about 500 Hz to about 1000 Hz, about 600 Hz toabout 700 Hz, about 600 Hz to about 800 Hz, about 600 Hz to about 900Hz, about 600 Hz to about 1000 Hz, about 700 Hz to about 800 Hz, about700 Hz to about 900 Hz, about 700 Hz to about 1000 Hz, about 800 Hz toabout 900 Hz, about 800 Hz to about 1000 Hz, or about 900 Hz to about1000 Hz.

In some embodiments, one or more near-infrared light source 170 are eachconfigured to emit near infrared light in a pulse wave (or frequency)range of about 1000 Hz to about 5000 Hz. In some embodiments,near-infrared light source 170 emits light having a pulse wave of, e.g.,about 1000 Hz, about 2000 Hz, about 3000 Hz, about 4000 Hz, or about5000 Hz. In some embodiments, near-infrared light source 170 emits lighthaving a pulse wave of, e.g., at least 1000 Hz, at least 2000 Hz, atleast 3000 Hz, at least 4000 Hz, or at least 5000 Hz. In someembodiments, near-infrared light source 170 emits light having a pulsewave of, e.g., at most 1000 Hz, at most 2000 Hz, at most 3000 Hz, atmost 4000 Hz, or at most 5000 Hz. In some embodiments, near-infraredlight source 170 emits light having a pulse wave of, e.g., about 1000 Hzto about 2000 Hz, about 1000 Hz to about 3000 Hz, about 1000 Hz to about4000 Hz, about 1000 Hz to about 5000 Hz, about 2000 Hz to about 3000 Hz,about 2000 Hz to about 4000 Hz, about 2000 Hz to about 5000 Hz, about3000 Hz to about 4000 Hz, about 3000 Hz to about 5000 Hz, or about 4000Hz to about 5000 Hz.

In some embodiments, one or more near-infrared light source 170 are eachconfigured to emit near infrared light in a radiant energy range ofabout 100 J to about 1100 J. In some embodiments, near-infrared lightsource 170 has a radiant energy of, e.g., about 100 J, about 200 J,about 300 J, about 400 J, about 500 J, about 600 J, about 700 J, about800 J, about 900 J, about 1000 J, or about 1100 J. In some embodiments,near-infrared light source 170 has a radiant energy of, e.g., at least100 J, at least 200 J, at least 300 J, at least 400 J, at least 500 J,at least 600 J, at least 700 J, at least 800 J, at least 900 J, at least1000 J, or at least 1100 J. In some embodiments, near-infrared lightsource 170 has a radiant energy of, e.g., at most 100 J, at most 200 J,at most 300 J, at most 400 J, at most 500 J, at most 600 J, at most 700J, at most 800 J, at most 900 J, at most 1000 J, or at most 1100 J. Insome embodiments, near-infrared light source 170 has a radiant energyof, e.g., about 100 J to about 200 J, about 100 J to about 300 J, about100 J to about 400 J, about 100 J to about 500 J, about 100 J to about600 J, about 100 J to about 700 J, about 100 J to about 800 J, about 100J to about 900 J, about 100 J to about 1000 J, about 100 J to about 1100J, about 200 J to about 300 J, about 200 J to about 400 J, about 200 Jto about 500 J, about 200 J to about 600 J, about 200 J to about 700 J,about 200 J to about 800 J, about 200 J to about 900 J, about 200 J toabout 1000 J, about 200 J to about 1100 J, about 300 J to about 400 J,about 300 J to about 500 J, about 300 J to about 600 J, about 300 J toabout 700 J, about 300 J to about 800 J, about 300 J to about 900 J,about 300 J to about 1000 J, about 300 J to about 1100 J, about 400 J toabout 500 J, about 400 J to about 600 J, about 400 J to about 700 J,about 400 J to about 800 J, about 400 J to about 900 J, about 400 J toabout 1000 J, about 400 J to about 1100 J, about 500 J to about 600 J,about 500 J to about 700 J, about 500 J to about 800 J, about 500 J toabout 900 J, about 500 J to about 1000 J, about 500 J to about 1100 J,about 600 J to about 700 J, about 600 J to about 800 J, about 600 J toabout 900 J, about 600 J to about 1000 J, about 600 J to about 1100 J,about 700 J to about 800 J, about 700 J to about 900 J, about 700 J toabout 1000 J, about 700 J to about 1100 J, about 800 J to about 900 J,about 800 J to about 1000 J, about 800 J to about 1100 J, about 900 J toabout 1000 J, about 900 J to about 1100 J, or about 1000 J to about 1100J.

In some embodiments, one or more near-infrared light source 170 are eachconfigured to emit near infrared light in an irradiance (flux density)range of about 5 mW/cm² to about 100 mW/cm². In some embodiments,near-infrared light source 170 has an irradiance (flux density) of,e.g., about 5 mW/cm², about 10 mW/cm², about 15 mW/cm², about 20 mW/cm²,about 25 mW/cm², about 30 mW/cm², about 35 mW/cm², about 40 mW/cm²,about 50 mW/cm², about 60 mW/cm², about 70 mW/cm², about 80 mW/cm²,about 90 mW/cm², or about 100 mW/cm² In some embodiments, near-infraredlight source 170 has an irradiance (flux density) of, e.g., at least 5mW/cm², at least 10 mW/cm², at least 15 mW/cm², at least 20 mW/cm², atleast 25 mW/cm², at least 30 mW/cm², at least 35 mW/cm², at least 40mW/cm², at least 50 mW/cm², at least 60 mW/cm², at least 70 mW/cm², atleast 80 mW/cm², at least 90 mW/cm², or at least 100 mW/cm² In someembodiments, near-infrared light source 170 has an irradiance (fluxdensity) of, e.g., at most 5 mW/cm², at most 10 mW/cm², at most 15mW/cm², at most 20 mW/cm², at most 25 mW/cm², at most 30 mW/cm², at most35 mW/cm², at most 40 mW/cm², at most 50 mW/cm², at most 60 mW/cm², atmost 70 mW/cm², at most 80 mW/cm², at most 90 mW/cm², or at most 100mW/cm² In some embodiments, near-infrared light source 170 has anirradiance (flux density) of, e.g., about 5 mW/cm² to about 10 mW/cm²,about 5 mW/cm² to about 15 mW/cm², about 5 mW/cm² to about 20 mW/cm²,about 5 mW/cm² to about 25 mW/cm², about 5 mW/cm² to about 30 mW/cm²,about 5 mW/cm² to about 35 mW/cm², about 10 mW/cm² to about 15 mW/cm²,about 10 mW/cm² to about 20 mW/cm², about 10 mW/cm² to about 25 mW/cm²,about 10 mW/cm² to about 30 mW/cm², about 10 mW/cm² to about 35 mW/cm²,about 15 mW/cm² to about 20 mW/cm², about 15 mW/cm² to about 25 mW/cm²,about 15 mW/cm² to about 30 mW/cm², about 15 mW/cm² to about 35 mW/cm²,about 20 mW/cm² to about 25 mW/cm², about 20 mW/cm² to about 30 mW/cm²,about 20 mW/cm² to about 35 mW/cm², about 25 mW/cm² to about 30 mW/cm²,about 25 mW/cm² to about 35 mW/cm², or about 30 mW/cm² to about 35mW/cm². In some embodiments, near-infrared light source 170 has anirradiance (flux density) of, e.g., about 20 mW/cm² to about 50 mW/cm²,about 20 mW/cm² to about 60 mW/cm², about 20 mW/cm² to about 70 mW/cm²,about 20 mW/cm² to about 80 mW/cm², about 20 mW/cm² to about 90 mW/cm²,about 20 mW/cm² to about 100 mW/cm², about 30 mW/cm² to about 60 mW/cm²,about 30 mW/cm² to about 70 mW/cm², about 30 mW/cm² to about 80 mW/cm²,about 30 mW/cm² to about 90 mW/cm², about 30 mW/cm² to about 100 mW/cm²,about 40 mW/cm² to about 60 mW/cm², about 40 mW/cm² to about 70 mW/cm²,about 40 mW/cm² to about 80 mW/cm², about 40 mW/cm² to about 90 mW/cm²,about 40 mW/cm² to about 100 mW/cm², about 50 mW/cm² to about 60 mW/cm²,about 50 mW/cm² to about 70 mW/cm², about 50 mW/cm² to about 80 mW/cm²,about 50 mW/cm² to about 90 mW/cm², about 50 mW/cm² to about 100 mW/cm²,about 60 mW/cm² to about 70 mW/cm², about 60 mW/cm² to about 80 mW/cm²,about 60 mW/cm² to about 90 mW/cm², about 60 mW/cm² to about 100 mW/cm²,about 70 mW/cm² to about 80 mW/cm², about 70 mW/cm² to about 90 mW/cm²,about 70 mW/cm² to about 100 mW/cm², about 80 mW/cm² to about 90 mW/cm²,about 80 mW/cm² to about 100 mW/cm², or about 90 mW/cm² to about 100mW/cm².

In some embodiments, one or more near-infrared light source 170 are eachconfigured to emit near infrared light in an irradiance (flux density)range of about 100 mW/cm² to about 1000 mW/cm². In some embodiments,near-infrared light source 170 has an irradiance (flux density) of,e.g., about 100 mW/cm², about 200 mW/cm², about 300 mW/cm², about 400mW/cm², about 500 mW/cm², about 600 mW/cm², about 700 mW/cm², about 800mW/cm², about 900 mW/cm², or about 1000 mW/cm². In some embodiments,near-infrared light source 170 has an irradiance (flux density) of,e.g., at least 100 mW/cm², at least 200 mW/cm², at least 300 mW/cm², atleast 400 mW/cm², at least 500 mW/cm², at least 600 mW/cm², at least 700mW/cm², at least 800 mW/cm², at least 900 mW/cm², or at least 1000mW/cm². In some embodiments, near-infrared light source 170 has anirradiance (flux density) of, e.g., at most 100 mW/cm², at most 200mW/cm², at most 300 mW/cm², at most 400 mW/cm², at most 500 mW/cm², atmost 600 mW/cm², at most 700 mW/cm², at most 800 mW/cm², at most 900mW/cm², or at most 1000 mW/cm². In some embodiments, near-infrared lightsource 170 has an irradiance (flux density) of, e.g., about 100 mW/cm²to about 200 mW/cm², about 100 mW/cm² to about 300 mW/cm², about 100mW/cm² to about 400 mW/cm², about 100 mW/cm² to about 500 mW/cm², about100 mW/cm² to about 600 mW/cm², about 100 mW/cm² to about 700 mW/cm²,about 100 mW/cm² to about 800 mW/cm², about 100 mW/cm² to about 900mW/cm², about 100 mW/cm² to about 1000 mW/cm², about 200 mW/cm² to about300 mW/cm², about 200 mW/cm² to about 400 mW/cm², about 200 mW/cm² toabout 500 mW/cm², about 200 mW/cm² to about 600 mW/cm², about 200 mW/cm²to about 700 mW/cm², about 200 mW/cm² to about 800 mW/cm², about 200mW/cm² to about 900 mW/cm², about 200 mW/cm² to about 1000 mW/cm², about300 mW/cm² to about 400 mW/cm², about 300 mW/cm² to about 500 mW/cm²,about 300 mW/cm² to about 600 mW/cm², about 300 mW/cm² to about 700mW/cm², about 300 mW/cm² to about 800 mW/cm², about 300 mW/cm² to about900 mW/cm², about 300 mW/cm² to about 1000 mW/cm², about 400 mW/cm² toabout 500 mW/cm², about 400 mW/cm² to about 600 mW/cm², about 400 mW/cm²to about 700 mW/cm², about 400 mW/cm² to about 800 mW/cm², about 400mW/cm² to about 900 mW/cm², about 400 mW/cm² to about 1000 mW/cm², about500 mW/cm² to about 600 mW/cm², about 500 mW/cm² to about 700 mW/cm²,about 500 mW/cm² to about 800 mW/cm², about 500 mW/cm² to about 900mW/cm², about 500 mW/cm² to about 1000 mW/cm², about 600 mW/cm² to about700 mW/cm², about 600 mW/cm² to about 800 mW/cm², about 600 mW/cm² toabout 900 mW/cm², about 600 mW/cm² to about 1000 mW/cm², about 700mW/cm² to about 800 mW/cm², about 700 mW/cm² to about 900 mW/cm², about700 mW/cm² to about 1000 mW/cm², about 800 mW/cm² to about 900 mW/cm²,about 800 mW/cm² to about 1000 mW/cm², or about 900 mW/cm² to about 1000mW/cm².

In some embodiments, one or more near-infrared light source 170 are eachconfigured to emit near infrared light in a radiant exposure (fluence)range of about 5 J/cm² to about 100 J/cm². In some embodiments,near-infrared light source 170 has a radiant exposure (fluence) of,e.g., about 5 J/cm², about 10 J/cm², about 15 J/cm², about 20 J/cm²,about 30 J/cm², about 40 J/cm², about 50 J/cm², about 70 J/cm², about 70J/cm², about 75 J/cm², about 80 J/cm², about 90 J/cm², or about 100J/cm² In some embodiments, near-infrared light source 170 has a radiantexposure (fluence) of, e.g., at least 5 J/cm², at least 10 J/cm², atleast 15 J/cm², at least 20 J/cm², at least 30 J/cm², at least 40 J/cm²,at least 50 J/cm², at least 70 J/cm², at least 70 J/cm², at least 75J/cm², at least 80 J/cm², at least 90 J/cm², or at least 100 J/cm² Insome embodiments, near-infrared light source 170 has a radiant exposure(fluence) of, e.g., at most 5 J/cm², at most 10 J/cm², at most 15 J/cm²,at most 20 J/cm², at most 30 J/cm², at most 40 J/cm², at most 50 J/cm²,at most 70 J/cm², at most 70 J/cm², at most 75 J/cm², at most 80 J/cm²,at most 90 J/cm², or at most 100 J/cm². In some embodiments,near-infrared light source 170 has a radiant exposure (fluence) of,e.g., about 5 J/cm² to about 10 J/cm², about 5 J/cm² to about 15 J/cm²,about 5 J/cm² to about 20 J/cm², about 5 J/cm² to about 30 J/cm², about5 J/cm² to about 40 J/cm², about 5 J/cm² to about 50 J/cm², about 5J/cm² to about 60 J/cm², about 5 J/cm² to about 70 J/cm², about 5 J/cm²to about 75 J/cm², about 5 J/cm² to about 80 J/cm², about 5 J/cm² toabout 90 J/cm², about 5 J/cm² to about 100 J/cm², about 10 J/cm² toabout 15 J/cm², about 10 J/cm² to about 20 J/cm², about 10 J/cm² toabout 30 J/cm², about 10 J/cm² to about 40 J/cm², about 10 J/cm² toabout 50 J/cm², about 10 J/cm² to about 60 J/cm², about 10 J/cm² toabout 70 J/cm², about 10 J/cm² to about 75 J/cm², about 10 J/cm² toabout 80 J/cm², about 10 J/cm² to about 90 J/cm², about 10 J/cm² toabout 100 J/cm², about 20 J/cm² to about 30 J/cm², about 20 J/cm² toabout 40 J/cm², about 20 J/cm² to about 50 J/cm², about 20 J/cm² toabout 60 J/cm², about 20 J/cm² to about 70 J/cm², about 20 J/cm² toabout 75 J/cm², about 20 J/cm² to about 80 J/cm², about 20 J/cm² toabout 90 J/cm², about 20 J/cm² to about 100 J/cm², about 30 J/cm² toabout 40 J/cm², about 30 J/cm² to about 50 J/cm², about 30 J/cm² toabout 60 J/cm², about 30 J/cm² to about 70 J/cm², about 30 J/cm² toabout 75 J/cm², about 30 J/cm² to about 80 J/cm², about 30 J/cm² toabout 90 J/cm², about 30 J/cm² to about 100 J/cm², about 40 J/cm² toabout 50 J/cm², about 40 J/cm² to about 60 J/cm², about 40 J/cm² toabout 70 J/cm², about 40 J/cm² to about 75 J/cm², about 40 J/cm² toabout 80 J/cm², about 40 J/cm² to about 90 J/cm², about 40 J/cm² toabout 100 J/cm², about 50 J/cm² to about 60 J/cm², about 50 J/cm² toabout 70 J/cm², about 50 J/cm² to about 75 J/cm², about 50 J/cm² toabout 80 J/cm², about 50 J/cm² to about 90 J/cm², about 50 J/cm² toabout 100 J/cm², about 60 J/cm² to about 70 J/cm², about 60 J/cm² toabout 80 J/cm², about 60 J/cm² to about 90 J/cm², about 60 J/cm² toabout 100 J/cm², about 70 J/cm² to about 80 J/cm², about 70 J/cm² toabout 90 J/cm², about 70 J/cm² to about 100 J/cm², about 80 J/cm² toabout 90 J/cm², about 80 J/cm² to about 100 J/cm², or about 90 J/cm² toabout 100 J/cm².

In some embodiments, one or more near-infrared light source 170 are eachconfigured to emit near infrared light in a radiant exposure (fluence)range of about 100 J/cm² to about 1000 J/cm². In some embodiments,near-infrared light source 170 has a radiant exposure (fluence) of,e.g., about 100 J/cm², about 200 J/cm², about 300 J/cm², about 400J/cm², about 500 J/cm², about 600 J/cm², about 700 J/cm², about 800J/cm², about 900 J/cm², or about 1000 J/cm². In some embodiments,near-infrared light source 170 has a radiant exposure (fluence) of,e.g., at least 100 J/cm², at least 200 J/cm², at least 300 J/cm², atleast 400 J/cm², at least 500 J/cm², at least 600 J/cm², at least 700J/cm², at least 800 J/cm², at least 900 J/cm², or at least 1000 J/cm².In some embodiments, near-infrared light source 170 has a radiantexposure (fluence) of, e.g., at most 100 J/cm², at most 200 J/cm², atmost 300 J/cm², at most 400 J/cm², at most 500 J/cm², at most 600 J/cm²,at most 700 J/cm², at most 800 J/cm², at most 900 J/cm², or at most 1000J/cm². In some embodiments, near-infrared light source 170 has a radiantexposure (fluence) of, e.g., about 100 J/cm² to about 200 J/cm², about100 J/cm² to about 300 J/cm², about 100 J/cm² to about 400 J/cm², about100 J/cm² to about 500 J/cm², about 100 J/cm² to about 600 J/cm², about100 J/cm² to about 700 J/cm², about 100 J/cm² to about 800 J/cm², about100 J/cm² to about 900 J/cm², about 100 J/cm² to about 1000 J/cm², about200 J/cm² to about 300 J/cm², about 200 J/cm² to about 400 J/cm², about200 J/cm² to about 500 J/cm², about 200 J/cm² to about 600 J/cm², about200 J/cm² to about 700 J/cm², about 200 J/cm² to about 800 J/cm², about200 J/cm² to about 900 J/cm², about 200 J/cm² to about 1000 J/cm², about300 J/cm² to about 400 J/cm², about 300 J/cm² to about 500 J/cm², about300 J/cm² to about 600 J/cm², about 300 J/cm² to about 700 J/cm², about300 J/cm² to about 800 J/cm², about 300 J/cm² to about 900 J/cm², about300 J/cm² to about 1000 J/cm², about 400 J/cm² to about 500 J/cm², about400 J/cm² to about 600 J/cm², about 400 J/cm² to about 700 J/cm², about400 J/cm² to about 800 J/cm², about 400 J/cm² to about 900 J/cm², about400 J/cm² to about 1000 J/cm², about 500 J/cm² to about 600 J/cm², about500 J/cm² to about 700 J/cm², about 500 J/cm² to about 800 J/cm², about500 J/cm² to about 900 J/cm², about 500 J/cm² to about 1000 J/cm², about600 J/cm² to about 700 J/cm², about 600 J/cm² to about 800 J/cm², about600 J/cm² to about 900 J/cm², about 600 J/cm² to about 1000 J/cm², about700 J/cm² to about 800 J/cm², about 700 J/cm² to about 900 J/cm², about700 J/cm² to about 1000 J/cm², about 800 J/cm² to about 900 J/cm², about800 J/cm² to about 1000 J/cm², or about 900 J/cm² to about 1000 J/cm².

In some embodiments, near-infrared light source 170 is a high poweredinfrared light source. In some embodiments, a high powered near-infraredlight source has a radiant flux (power) of, e.g., about 400 mW, about425 mW, about 450 mW, about 500 mW, about 525 mW, about 550 mW, about575 mW or about 600 mW. In some embodiments, a high powerednear-infrared light source has a radiant flux (power) of, e.g., at least400 mW, at least 425 mW, at least 450 mW, at least 500 mW, at least 525mW, at least 550 mW, at least 575 mW or at least 600 mW. In someembodiments, a high powered near-infrared light source has a radiantflux (power) of, e.g., at most 400 mW, at most 425 mW, at most 450 mW,at most 500 mW, at most 525 mW, at most 550 mW, at most 575 mW or atmost 600 mW. In some embodiments, a high powered near-infrared lightsource has a radiant flux (power) of, e.g., about 400 mW to about 450mW, about 400 mW to about 500 mW, about 400 mW to about 550 mW, about400 mW to about 600 mW, about 450 mW to about 500 mW, about 450 mW toabout 550 mW, about 450 mW to about 600 mW, about 500 mW to about 550mW, about 500 mW to about 600 mW, or about 550 mW to about 600 mW.

In some embodiments, a high powered near-infrared light source has aradiant flux (power) of, e.g., about 100 mW, about 200 mW, about 300 mW,about 400 mW, about 500 mW, about 600 mW, about 700 mW, about 800 mW,about 900 mW, or about 1000 mW. In some embodiments, a high powerednear-infrared light source has a radiant flux (power) of, e.g., at least100 mW, at least 200 mW, at least 300 mW, at least 400 mW, at least 500mW, at least 600 mW, at least 700 mW, at least 800 mW, at least 900 mW,or at least 1000 mW. In some embodiments, a high powered near-infraredlight source has a radiant flux (power) of, e.g., at most 100 mW, atmost 200 mW, at most 300 mW, at most 400 mW, at most 500 mW, at most 600mW, at most 700 mW, at most 800 mW, at most 900 mW, or at most 1000 mW.In some embodiments, a high powered near-infrared light source has aradiant flux (power) of, e.g., about 100 mW to about 200 mW, about 100mW to about 300 mW, about 100 mW to about 400 mW, about 100 mW to about500 mW, about 100 mW to about 600 mW, about 100 mW to about 700 mW,about 100 mW to about 800 mW, about 100 mW to about 900 mW, about 100 mWto about 1000 mW, about 200 mW to about 300 mW, about 200 mW to about400 mW, about 200 mW to about 500 mW, about 200 mW to about 600 mW,about 200 mW to about 700 mW, about 200 mW to about 800 mW, about 200 mWto about 900 mW, about 200 mW to about 1000 mW, about 300 mW to about400 mW, about 300 mW to about 500 mW, about 300 mW to about 600 mW,about 300 mW to about 700 mW, about 300 mW to about 800 mW, about 300 mWto about 900 mW, about 300 mW to about 1000 mW, about 400 mW to about500 mW, about 400 mW to about 600 mW, about 400 mW to about 700 mW,about 400 mW to about 800 mW, about 400 mW to about 900 mW, about 400 mWto about 1000 mW, about 500 mW to about 600 mW, about 500 mW to about700 mW, about 500 mW to about 800 mW, about 500 mW to about 900 mW,about 500 mW to about 1000 mW, about 600 mW to about 700 mW, about 600mW to about 800 mW, about 600 mW to about 900 mW, about 600 mW to about1000 mW, about 700 mW to about 800 mW, about 700 mW to about 900 mW,about 700 mW to about 1000 mW, about 800 mW to about 900 mW, about 800mW to about 1000 mW, or about 900 mW to about 1000 mW.

In some embodiments, a high powered near-infrared light source has aradiant intensity (brightness) of, e.g., about 150 mW/sr, about 200mW/sr, about 250 mW/sr, about 300 mW/sr, about 350 mW/sr, about 400mW/sr, about 450 mW/sr, about 500 mW/sr, about 550 mW/sr, about 600mW/sr, about 650 mW/sr, about 700 mW/sr, or about 750 mW/sr. In someembodiments, a high powered near-infrared light source has a radiantintensity (brightness) of, e.g., at least 150 mW/sr, at least 200 mW/sr,at least 250 mW/sr, at least 300 mW/sr, at least 350 mW/sr, at least 400mW/sr, at least 450 mW/sr, at least 500 mW/sr, at least 550 mW/sr, atleast 600 mW/sr, at least 650 mW/sr, at least 700 mW/sr, or at least 750mW/sr. In some embodiments, a high powered near-infrared light sourcehas a radiant intensity (brightness) of, e.g., at most 150 mW/sr, atmost 200 mW/sr, at most 250 mW/sr, at most 300 mW/sr, at most 350 mW/sr,at most 400 mW/sr, at most 450 mW/sr, at most 500 mW/sr, at most 550mW/sr, at most 600 mW/sr, at most 650 mW/sr, at most 700 mW/sr, or atmost 750 mW/sr. In some embodiments, a high powered near-infrared lightsource has a brightness range (or radiant intensity) of, e.g., about 150mW/sr to about 200 mW/sr, about 150 mW/sr to about 300 mW/sr, about 150mW/sr to about 400 mW/sr, about 150 mW/sr to about 500 mW/sr, about 150mW/sr to about 600 mW/sr, about 150 mW/sr to about 700 mW/sr, about 150mW/sr to about 800 mW/sr, about 200 mW/sr to about 300 mW/sr, about 200mW/sr to about 400 mW/sr, about 200 mW/sr to about 500 mW/sr, about 200mW/sr to about 600 mW/sr, about 200 mW/sr to about 700 mW/sr, about 200mW/sr to about 800 mW/sr, about 300 mW/sr to about 400 mW/sr, about 300mW/sr to about 500 mW/sr, about 300 mW/sr to about 600 mW/sr, about 300mW/sr to about 700 mW/sr, about 300 mW/sr to about 800 mW/sr, about 400mW/sr to about 500 mW/sr, about 400 mW/sr to about 600 mW/sr, about 400mW/sr to about 700 mW/sr, about 400 mW/sr to about 800 mW/sr, about 500mW/sr to about 600 mW/sr, about 500 mW/sr to about 700 mW/sr, about 500mW/sr to about 800 mW/sr, about 600 mW/sr to about 700 mW/sr, about 600mW/sr to about 800 mW/sr, or about 700 mW/sr to about 800 mW/sr.

In some embodiments, near-infrared light source 170 is a low poweredinfrared light source. In some embodiments, a low powered near-infraredlight source has a radiant flux (power) of, e.g., about 30 mW, about 35mW, about 40 mW, about 45 mW, about 50 mW, about 55 mW, about 60 mW,about 65 mW, about 70 mW, or about 75 mW. In some embodiments, a lowpowered near-infrared light source has a radiant flux (power) of, e.g.,at least 30 mW, at least 35 mW, at least 40 mW, at least 45 mW, at least50 mW, at least 55 mW, at least 60 mW, at least 65 mW, at least 70 mW,or at least 75 mW. In some embodiments, a low powered near-infraredlight source has a radiant flux (power) of, e.g., at most 30 mW, at most35 mW, at most 40 mW, at most 45 mW, at most 50 mW, at most 55 mW, atmost 60 mW, at most 65 mW, at most 70 mW, or at most 75 mW. In someembodiments, a low powered near-infrared light source has a radiant flux(power) of, e.g., about 30 mW to about 40 mW, about 30 mW to about 50mW, about 30 mW to about 60 mW, about 30 mW to about 70 mW, about 30 mWto about 75 mW, about 40 mW to about 50 mW, about 40 mW to about 60 mW,about 40 mW to about 70 mW, about 40 mW to about 75 mW, about 50 mW toabout 60 mW, about 50 mW to about 70 mW, about 50 mW to about 75 mW,about 60 mW to about 70 mW, or about 60 mW to about 75 mW.

In some embodiments, a low powered near-infrared light source isconfigured to have a radiant intensity (brightness) of, e.g., about 25mW/sr, about 50 mW/sr, about 75 mW/sr, about 100 mW/sr, about 125 mW/sr,or about 150 mW/sr. In some embodiments, a low powered near-infraredlight source has a brightness (or radiant intensity) of, e.g., at least25 mW/sr, at least 50 mW/sr, at least 75 mW/sr, at least 100 mW/sr, atleast 125 mW/sr, or at least 150 mW/sr. In some embodiments,near-infrared light source 170 has a radiant intensity (brightness) of,e.g., at most 25 mW/sr, at most 50 mW/sr, at most 75 mW/sr, at most 100mW/sr, at most 125 mW/sr, or at most 150 mW/sr. In some embodiments, alow powered near-infrared light source has a radiant intensity(brightness) of, e.g., about 25 mW/sr to about 50 mW/sr, about 25 mW/srto about 75 mW/sr, about 25 mW/sr to about 100 mW/sr, about 25 mW/sr toabout 125 mW/sr, about 25 mW/sr to about 150 mW/sr, about 50 mW/sr toabout 75 mW/sr, about 50 mW/sr to about 100 mW/sr, about 50 mW/sr toabout 125 mW/sr, about 50 mW/sr to about 150 mW/sr, about 75 mW/sr toabout 100 mW/sr, about 75 mW/sr to about 125 mW/sr, about 75 mW/sr toabout 150 mW/sr, about 100 mW/sr to about 125 mW/sr, about 100 mW/sr toabout 150 mW/sr, or about 125 mW/sr to about 150 mW/sr.

Referring to FIGS. 9-15, photobiomodulation unit 100 also includes oneor more sensors 180 configured to detect and collect information on oneor more parameters including operational information of aphotobiomodulation therapy garment 20, biometric information of theuser, or other useful information to ensure proper use and efficacy.Operational information includes, without limitation, positional andsafety information of photobiomodulation therapy garment 20. Biometricinformation includes, without limitation, body measurements andcalculations related to the user. Non-limiting examples of a biometricsensor includes a neuro-conductivity sensor, a galvanometric sensor, anoxygen level sensor, a carbon dioxide level sensor, a brain oxygen levelsensor, a heart rate sensor, a cortical blood flow sensor, a temperaturesensor, an electroencephalogram sensor, or any combination thereof. Oneor more sensors 180 can also measure, record and analyze and/or transmitthe information to controller 200 where measurement, recording andanalysis of the information can be performed.

In one or more embodiments, as shown in FIGS. 9, 11, 15, & 16, sensorcover 79 and one or more sensors 180 thereunder or nearby are positionedbetween second near-infrared light source grouping 172 and fifthnear-infrared light source grouping 175. This position of sensor cover79 places it and one or more sensors 180 thereunder substantially oversagittal plane 320 of the forehead area. In some embodiments, wheresecond near-infrared light source grouping 172 and/or fifthnear-infrared light sources grouping 175 is not present, sensor cover 79and one or more sensors 180 thereunder or nearby can be positioned onphotobiomodulation therapy headband 22 at a position configured to placesensor cover 79 substantially on top of sagittal plane 320 when properlydonned. In some embodiments, sensor cover 79 and one or more sensors 180thereunder or nearby are positioned between first near-infrared lightsource grouping 171 and fourth near-infrared light source grouping 174.In some embodiments, sensor cover 79 and one or more sensors 180thereunder or nearby are positioned between third near-infrared lightsource grouping 173 and sixth near-infrared light source grouping 176.In some embodiments, where two sensors 180 require to be spaced apartfor proper functioning, one sensor cover 79 and one or more sensors 180thereunder or nearby are positioned between first near-infrared lightsource grouping 171 and fourth near-infrared light source grouping 174(or outside such groups in the direction towards left portion 56) andone sensor cover 79 and one or more sensors 180 thereunder or nearby arepositioned between third near-infrared light source grouping 173 andsixth near-infrared light source grouping 176 (or outside such groups inthe direction towards right portion 54).

In some embodiments, sensors 180 include a heart rate sensor and atemperature sensor. Referring to FIGS. 9 & 11-14, one or more sensor 180includes cardiovascular sensor 182 which detects blood pulse, oxygenlevels, as well as other cardiovascular characteristics. Referring toFIG. 10, which is a longitudinal cross-section of sensor mountingportion 142, cardiovascular sensor 182 comprises LED light sources 184,186 and a photodetector 188. Light from LED light sources 184, 186 isshone on blood vessels just under skin surface S; and the portion oflight reflected back is captured by photodetector 188. The signal fromcardiovascular sensor 182 is transmitted to controller 200 fordetermining the user's cardiovascular parameters. Similarly, referringto FIGS. 9 & 11-14, one or more sensor 180 includes a temperature sensor192 which detects skin parameters, such as, e.g., skin temperature, skindensity, and skin opaqueness (color). The signal from temperature sensor192 is transmitted to controller 200 for determining the user's skinparameters.

Photobiomodulation unit 100 can optionally include one or morestimulators 194 configured to administer a brain stimulatory orinhibitory signal. Non-limiting examples of a stimulator include acomponent that can generate a magnetic field useful for stimulatingnerve cells in the brain, such as, e.g., a magnetic material of amaterial that can be magnetized using an electrical current (anelectromagnet). Such a magnetic field generating component can be usedto administer a transcranial magnetic stimulation therapy. In someembodiments, one or more stimulators 194 are operationally mounted toelectronic circuitry connector 162 or sensor liquid wire tube 158 whichcontains the electronic circuitry needed to establish electricalcommunication between each of the one or more stimulators 194 andconnection terminal 160.

Referring to FIGS. 1, 6 & 7, photobiomodulation therapy garment 20 alsoincludes controller 200. In one or more embodiments, controller 200includes a housing enclosing an input, a hardware processor, a memory,and an output, and may include one or more of each of these elements. Inone or more example embodiments, controller 200 may include a singleboard computer, a system on a chip, or other similar and/or knowncomputing devices or circuits. The inputs can include one or more USBconnectors and/or a short-range wireless device (e.g., a BLUETOOTHmodule, a Wi-Fi module, or other wireless communications devices orsystems) for communicating with an external computer, such as a smartphone, desktop, laptop, tablet, other wearable computing device, server,and the like. Controller 200 can operate autonomously orsemi-autonomously, or may read executable software instructions, code,or other information from the memory or a computer-readable medium, ormay receive information or instructions via the input from a user, froma healthcare provider, or any another source logically connected to acomputer or device, such as another networked computer, server, orartificial intelligence (AI) or machine-learning system. In someembodiments, controller 200 can be remotely accessed and operated by athird-party individual, such as for example a healthcare worker, who canmonitor usage of, change operational parameters for, and/or collect datafrom photobiomodulation therapy garment 20, thereby providing a remotedigital healthcare platform that assists a user in receiving the mosteffective biomodulation therapy. In some embodiments, controller 200 canbe a “virtual controller” where access and operation ofphotobiomodulation therapy garment 20 by controller 200 is via cloudcomputing elements by either a healthcare provider, or any anothersource logically connected to a computer or device, such as anothernetworked computer or server or AI or machine learning-based system.Controller 200 can be assessed and operated by pre-programedinstructions and/or parameters, real-time instructions and/orparameters, or both.

Controller 200 is programmed to supply an electrical signal which powerseach of the one or more near-infrared light sources 170, each of the oneor more sensors 180, and each of the one or more stimulators 194. Inaddition, controller 200 in one or more embodiments is a computingdevice which is programmed or configured to implement the methods andalgorithms which can operationally control each of the one or morenear-infrared light sources 170, each of the one or more sensors 180,and each of the one or more stimulators 194. For example, in someembodiments, controller 200 operational controls one or more of theoperation times of the one or more near-infrared light sources 170, thefluence level of the one or more near-infrared light sources 170, theirradiance level of the one or more near-infrared light sources 170,whether the one or more near-infrared light sources 170 are operatedcontinuously or pulsed, which one or more of the one or morenear-infrared light sources 170 are activated or deactivated, andpredetermined dosimetry levels. In addition, controller 200operationally controls each of the one or more sensors 180 and receivesand analyzes information collected from each of the one or more sensors180. In some embodiments, controller 200 operationally controls one ormore of the operation times of the one or more stimulators 194, thepower level of the one or more stimulators 194, whether the one or morestimulators 194 are operated continuously or pulsed, which one or moreof the one or more stimulators 194 are activated or deactivated, or anycombination thereof.

In some embodiments, controller 200 operationally instructs activatingone or more infrared light sources 170 on the left side of midsagittalplane 320 and deactivating one or more infrared light sources 170 on theright side of midsagittal plane 320, or vice versa. In some embodiments,controller 200 operationally instructs activating one or more infraredlight sources 170 on the left side and right side of midsagittal plane320 while activating one or more infrared light sources 170 on the leftside of midsagittal plane 320 at a higher level of irradiance relativeto one or more infrared light sources 170 on the right side ofmidsagittal plane 320, or vice versa.

In some embodiments, controller 200 dynamically adjusts operationalparameters of photobiomodulation therapy garment 20 using informationcollected from each of the one or more sensors 180, information providedby the user, or information remotely inputted by a third-partyindividual. Such information input is then processed by controller 200relative to information stored in an operational database in one or morealgorithms, and, based on the analysis performed in comparing collectedor provided or inputted with information stored in such a database withthe one or more algorithms, operational parameters of the one or morenear-infrared light sources 170, each of the one or more sensors 180,and each of the one or more stimulators 194 are adjusted by executableinstructions provided controller 200.

For example, cardiovascular sensor 182 obtains cardiovascular parametersfrom user during operation of photobiomodulation therapy garment 20 andthis input information is analyzed against cardiovascular parametersstored in an operational database in order to assess actualcardiovascular parameters and adjust operation of photobiomodulationtherapy garment 20 based on the therapy selected by the user orthird-party individual. In some embodiments, a detected decrease inheart rate variability by cardiovascular sensor 182 and sent tocontroller 200 would result in controller 200 providing executableinstructions to optimize the pulse wave by increasing the frequency oflight emitted from the one or more near-infrared light source 170 insituations where a user or third-party individual has selected analertness therapy. As an illustration, the initial pulse wave ofphotobiomodulation therapy garment 20 could be set at 40 Hz and basedupon the detected heart rate variability controller 200 would increasethe frequency of light emitted from the one or more near-infrared lightsource 170 to 50 Hz. Continuous monitoring and analysis of heart ratevariability by cardiovascular sensor 182 and controller 200 could resultin the 50 Hz pulse wave setting being maintained, or increased to 60 Hzor 70 Hz or more in order to establish the proper pulse wave for analertness therapy being emitted from the one or more near-infrared lightsource 170. Such dynamic monitoring of heart rate variability bycardiovascular sensor 182 and controller 200 would result in continuousadjustments to the pulse wave in order to achieve optimum pulse wave ofthe selected alertness therapy.

In some embodiments, a detected increase in heart rate variability bycardiovascular sensor 182 and sent to controller 200 would result incontroller 200 providing executable instructions to optimize the pulsewave by decreasing the frequency of light emitted from the one or morenear-infrared light source 170 in situations where a user or third-partyindividual has selected a calmness or relaxation therapy. As anillustration, the initial pulse wave of photobiomodulation therapygarment 20 could be set at 40 Hz and based upon the detected heart ratevariability controller 200 would decreasing the frequency of lightemitted from the one or more near-infrared light source 170 to 30 Hz.Continuous monitoring and analysis of heart rate variability bycardiovascular sensor 182 and controller 200 could result in the 30 Hzpulse wave setting being maintained, or decreased to 10 Hz or 1 Hz inorder to establish the proper pulse wave for a calmness or relaxationtherapy being emitted from the one or more near-infrared light source170. Such dynamic monitoring of heart rate variability by cardiovascularsensor 182 and controller 200 would result in continuous adjustments tothe pulse wave in order to achieve optimum pulse wave of the selectedcalmness or relaxation therapy.

As another example, skin sensor 192 obtains information on skinparameters from a user during operation of photobiomodulation therapygarment 20 and this input information is analyzed against skininformation stored in an operational database in order to assess actualskin parameters and adjust operation of photobiomodulation therapygarment 20 based on the therapy selected by the user or third-partyindividual. In some embodiments, a detected decrease in skin temperatureby skin sensor 192 and sent to controller 200 would result in controller200 providing executable instructions to optimize skin temperature byincreasing the irradiance of light emitted from the one or morenear-infrared light source 170 in situations where a user or third-partyindividual has selected an alertness therapy. As an illustration, theinitial irradiance of photobiomodulation therapy garment 20 could be setat 250 mW/cm² and based upon the detected skin temperature controller200 would increase the irradiance of light emitted from the one or morenear-infrared light source 170 to 500 mW/cm². Continuous monitoring andanalysis of skin temperature by skin sensor 192 and controller 200 couldresult in the 500 mW/cm² irradiance setting being maintained, orincreased to 750 mW/cm² or 1000 mW/cm² or more in order to establish theproper skin temperature for an alertness therapy. Such dynamicmonitoring of skin temperature by skin sensor 192 and controller 200would result in continuous adjustments to the irradiance in order toachieve optimum skin temperature of the selected alertness therapy.

In some embodiments, a detected increase in skin temperature by skinsensor 192 and sent to controller 200 would result in controller 200providing executable instructions to optimize skin temperature bydecreasing the irradiance of light emitted from the one or morenear-infrared light source 170 in situations where a user or third-partyindividual has selected a calmness or relaxation therapy. As anillustration, the initial irradiance of photobiomodulation therapygarment 20 could be set at 250 mW/cm² and based upon the detected skintemperature controller 200 would decrease the irradiance of lightemitted from the one or more near-infrared light source 170 to 100mW/cm². Continuous monitoring and analysis of skin temperature by skinsensor 192 and controller 200 could result in the 125 mW/cm² irradiancesetting being maintained, or decreased to 75 mW/cm² or 25 mW/cm² or lessin order to establish the proper skin temperature for a calmness orrelaxation therapy. Such dynamic monitoring of skin temperature by skinsensor 192 and controller 200 would result in continuous adjustments tothe irradiance in order to achieve optimum skin temperature of theselected calmness or relaxation herapy.

In some embodiments, a detected decrease in skin temperature by skinsensor 192 and sent to controller 200 would result in controller 200providing executable instructions to optimize skin temperature byincreasing the duty cycle of light emitted from the one or morenear-infrared light source 170 in situations where a user or third-partyindividual has selected an alertness therapy. As an illustration, theinitial duty cycle of photobiomodulation therapy garment 20 could be setat 50% and based upon the detected skin temperature controller 200 wouldincrease the duty cycle of light emitted from the one or morenear-infrared light source 170 to 60%. Continuous monitoring andanalysis of skin temperature by skin sensor 192 and controller 200 couldresult in the 60% duty cycle setting being maintained, or increased to75% or more in order to establish the proper skin temperature for analertness therapy. Such dynamic monitoring of skin temperature by skinsensor 192 and controller 200 would result in continuous adjustments tothe duty cycle in order to achieve optimum skin temperature of theselected alertness therapy.

In some embodiments, a detected increase in skin temperature by skinsensor 192 and sent to controller 200 would result in controller 200providing executable instructions to optimize skin temperature bydecreasing the duty cycle of light emitted from the one or morenear-infrared light source 170 in situations where a user or third-partyindividual has selected a calmness or relaxation therapy. As anillustration, the initial duty cycle of photobiomodulation therapygarment 20 could be set at 50% and based upon the detected skintemperature controller 200 would decrease the duty cycle of lightemitted from the one or more near-infrared light source 170 to 40%.Continuous monitoring and analysis of skin temperature by skin sensor192 and controller 200 could result in the 40% duty cycle setting beingmaintained, or decreased to 25% or less in order to establish the properskin temperature for an alertness therapy. Such dynamic monitoring ofskin temperature by skin sensor 192 and controller 200 would result incontinuous adjustments to the duty cycle in order to achieve optimumskin temperature of the selected calmness or relaxation therapy.

In some embodiments, a detected higher skin opacity, indicative skinwith higher melanin content, by skin sensor 192 and sent to controller200 would result in controller 200 providing executable instructions tooptimize skin penetration by adjusting the wavelength of light emittedfrom the one or more near-infrared light source 170, or a combination ofwavelengths, in order to provide optimal light penetration for theselected therapy. As an illustration, the initial wavelength ofphotobiomodulation therapy garment 20 could be set to 900 nm and basedupon the detected skin opacity controller 200 would increase thewavelength of light emitted from the one or more near-infrared lightsource 170 to about 970 nm. Continuous monitoring and analysis of skinopacity by skin sensor 192 and controller 200 could result in thewavelength setting being maintained, or increased to 1000 nm or more inorder to establish the proper wavelength penetration into the skin forthe selected therapy. Such dynamic monitoring of skin opacity by skinsensor 192 and controller 200 would result in continuous adjustments tothe wavelength in order to achieve optimum skin penetration of theselected therapy.

In some embodiments, a detected lower skin opacity, indicative skin withlower melanin content, by skin sensor 192 and sent to controller 200would result in controller 200 providing executable instructions tooptimize skin penetration by adjusting the wavelength of light emittedfrom the one or more near-infrared light source 170, or a combination ofwavelengths, in order to provide optimal light penetration for theselected therapy. As an illustration, the initial wavelength ofphotobiomodulation therapy garment 20 could be set to 900 nm and basedupon the detected skin opacity controller 200 would decrease thewavelength of light emitted from the one or more near-infrared lightsource 170 to about 810 nm. Continuous monitoring and analysis of skinopacity by skin sensor 192 and controller 200 could result in thewavelength setting being maintained, or decreased to 790 nm or less inorder to establish the proper wavelength penetration into the skin forthe selected therapy. Such dynamic monitoring of skin opacity by skinsensor 192 and controller 200 would result in continuous adjustments tothe wavelength in order to achieve optimum skin penetration of theselected therapy.

In some embodiments, a detected higher skin density, indicative skinwith higher fat content, by skin sensor 192 and sent to controller 200would result in controller 200 providing executable instructions tooptimize skin penetration by adjusting the wavelength of light emittedfrom the one or more near-infrared light source 170 in order to provideoptimal light penetration for the selected therapy. As an illustration,the initial wavelength of photobiomodulation therapy garment 20 could beset to 900 nm and based upon the detected skin density controller 200would increase the wavelength of light emitted from the one or morenear-infrared light source 170 to about 970 nm. Continuous monitoringand analysis of skin density by skin sensor 192 and controller 200 couldresult in the wavelength setting being maintained, or increased to 1000nm or more in order to establish the proper wavelength penetration intothe skin for the selected therapy. Such dynamic monitoring of skindensity by skin sensor 192 and controller 200 would result in continuousadjustments to the wavelength in order to achieve optimum skinpenetration of the selected therapy.

In some embodiments, a detected lower skin density, indicative skin withlower fat content, by skin sensor 192 and sent to controller 200 wouldresult in controller 200 providing executable instructions to optimizeskin penetration by adjusting the wavelength of light emitted from theone or more near-infrared light source 170 in order to provide optimallight penetration for the selected therapy. As an illustration, theinitial wavelength of photobiomodulation therapy garment 20 could be setto 900 nm and based upon the detected skin density controller 200 woulddecrease the wavelength of light emitted from the one or morenear-infrared light source 170 to about 810 nm. Continuous monitoringand analysis of skin density by skin sensor 192 and controller 200 couldresult in the wavelength setting being maintained, or decreased to 790nm or less in order to establish the proper wavelength penetration intothe skin for the selected therapy. Such dynamic monitoring of skindensity by skin sensor 192 and controller 200 would result in continuousadjustments to the wavelength in order to achieve optimum skinpenetration of the selected therapy.

As another example, information can be provided by a user or athird-party individual during operation of photobiomodulation therapygarment 20 and this input information is either used directly in orderto adjust operation of photobiomodulation therapy garment 20 based onthe therapy selected by the user, or analyzed against user-defined orthird-party individual defined information stored in an operationaldatabase in order to adjust operation of photobiomodulation therapygarment 20 based on the selected therapy. As an illustration, theinitial therapy of photobiomodulation therapy garment 20 could be set toan alertness therapy and based upon user input (such as, e.g., “stilltired” or “feel good”) or individual third-party input (based upon,e.g., monitoring of physiological or vital signs of user) controller 200would adjust the characteristics of the light being emitted from the oneor more near-infrared light source 170. Continuous user or individualthird-party input into controller 200 would establish the proper lightcharacteristics for the selected alertness therapy. Such dynamicmonitoring of user or individual third-party input into controller 200would result in continuous adjustments to the light characteristics inorder to achieve optimum effect of the selected alertness therapy.

As another example, sensor 180 obtains information on mitochondrialfunctionality from a user during operation of photobiomodulation therapygarment 20 and this input information is analyzed against mitochondrialfunctionality information stored in an operational database in order toassess actual mitochondrial functionality and adjust operation ofphotobiomodulation therapy garment 20 based on the therapy selected bythe user or third-party individual. As an illustration, the initialtherapy of photobiomodulation therapy garment 20 could be set to analertness therapy and based upon detected mitochondrial functionality(such as, e.g., NAD⁺ or NADH levels) controller 200 would adjust thecharacteristics of the light being emitted from the one or morenear-infrared light source 170. Continuous monitoring and analysis ofskin opacity by sensor 180 and controller 200 would establish the properlight characteristics for the selected alertness therapy being emittedfrom the one or more near-infrared light source 170. Such dynamicmonitoring of mitochondrial functionality by sensor 180 and controller200 would result in continuous adjustments to the light characteristicsin order to achieve optimum skin penetration of the selected alertnesstherapy.

The adjustments described in the examples in the paragraphs above madeby the controller 200, and the processing performed therein on thevarious types of information, may be performed in conjunction with amachine learning-based framework that applies elements of artificialintelligence (AI) to analyze the information provided as input withinmodels trained on historical or known data, such as that stored in theoperational database(s) referenced above, to improve such adjustments tooperational parameters of the one or more near-infrared light sources170, each of the one or more sensors 180, and each of the one or morestimulators 194. The present invention therefore may include such amachine learning-based framework, which may be comprised of multipleelements that perform, either together or as separately-instantiatedmodels, several of the processing aspects performed by the controller200.

The modeling performed within the machine learning-based framework maycomprise many different types of machine learning, and apply manydifferent mathematical approaches to analyzing information andgenerating outputs that improve outcomes in the continuous adjustmentsto the operational parameters of the one or more near-infrared lightsources 170, each of the one or more sensors 180, and each of the one ormore stimulators 194 that are described herein. For example, in someembodiments of the present invention, the machine learning-basedframework may be comprised of algorithms that apply techniques ofsupervised learning, reinforced learning, and other approaches ofmachine learning and artificial intelligence to further evaluate inputsinto the controller 200.

The machine learning-based framework may be comprised of any of severaldifferent mathematical approaches. These may include statisticalanalyses, which are non-deterministic mathematical approaches thatenable calculation of probabilities that events will or will not occur.Regression analyses are types of statistical analyses where models areused for estimating the relationships between variables of interest,such as for example a dependent variable and one or more independentvariables (often called ‘predictors’). This type of machine learning isused to infer causal relationships between the independent and dependentvariables, and for prediction and forecasting of outcomes where suchcausal relationships are impactful on future states for application ofthe overall modeling being performed. There are many types of regressionanalyses, such as linear and non-linear regression, and specificapproaches such as logistic regression, that enable the use of derivedparameters to interpret the importance of maximum values in form of thelog-odds when calculating probability values. For example, other typesof logistic functions, and other types of regression analyses, may alsobe utilized to calculate probabilities in the present invention, and arewithin the scope of the present invention. Other approaches that may beutilized include, but are not limited to, decision trees, random forestclassifiers, support vector machines, and probit. It is therefore to befurther understood that the present invention, and the presentspecification, are not to be limited to any one type of mathematicalmodel or statistical process mentioned herein, particularly as to itsapplication in the one or more layers of machine learning.

Modeling within the machine learning-based framework may also includeapplications of neural networks. Neural networks generally are comprisedof nodes, which are computational units having one or more biasedinput/output connections. Such biased connections act as transfer (oractivation) functions that combine inputs and outputs in some way. Nodesare organized into multiple layers that form the neural network. Thereare many types of neural networks, which are computing systems that“learn” to perform tasks, without being programmed with task-specificrules, based on examples.

Neural networks generally are based on arrays of connected, aggregatednodes (or, “neurons”) that transmit signals to each other in themultiple layers over the biased input/output connections. Connections,as noted above, are activation or transfer functions which “fire” thesenodes and combine inputs according to mathematical equations orformulas. Different types of neural networks generally have differentconfigurations of these layers of connected, aggregated nodes, but theycan generally be described as an input layer, a middle or ‘hidden’layer, and an output layer. These layers may perform differenttransformations on their various inputs, using different mathematicalcalculations or functions.

Signals are transmitted between nodes over connections, and the outputof each node is calculated in a non-linear function that sums all of theinputs to that node. Weight matrices and biases are typically applied toeach node, and each connection, and these weights and biases areadjusted as the neural network processes inputs and transmits themacross the nodes and connections. These weights represent increases ordecreases in the strength of a signal at a particular connection.Additionally, nodes may have a threshold, such that a signal is sentonly if the aggregated output at that node crosses that threshold.Weights generally represent how long an activation function takes, whilebiases represent when, in time, such a function starts; together, theyhelp gradients minimize over time. At least in the case of weights, theycan be initialized and change (i.e., decay) over time, as a systemlearns what weights should be, and how they should be adjusted. In otherwords, neural networks evolve as they learn, and the mathematicalformulas and functions that comprise neural networks design can changeover time as a system improves itself.

The application of neural networks within the machine learning-basedframework may include instantiations of different networks for differentpurposes. These include both “production” neural network(s), configuredto refine the algorithms performed within the overall modeling frameworkto generate output data (for example, as adjusted operational parametersof the one or more near-infrared light sources 170, each of the one ormore sensors 180, and each of the one or more stimulators 194), and“training” neural network(s), configured to train the productionnetwork(s) using improvements on the reasons for prior, historicaloutcomes that have been learned.

Recurrent neural networks are a name given to types of neural networksin which connections between nodes follow a directed temporal sequence,allowing the neural network to model temporal dynamic behavior andprocess sequences of inputs of variable length. These types of neuralnetworks are deployed where there is a need for recognizing, and/oracting on, such sequences. As with neural networks generally, there aremany types of recurrent neural networks.

Neural networks having a recurrent architecture may also have stored, orcontrolled, internal states which permit storage under direct control ofthe neural network, making them more suitable for inputs having atemporal nature. This storage may be in the form of connections or gateswhich act as time delays or feedback loops that permit a node orconnection to retain data that is prior in time for modeling suchtemporal dynamic behavior. Such controlled internal states are referredto as gated states or gated memory, and are part of long short-termmemory networks (LSTMs) and gated recurrent units (GRUs), which arenames of different types of recurrent neural network architectures. Thistype of neural network design is utilized where desired outputs of asystem are motivated by the need for memory, as storage, and as notedabove, where the system is designed for processing inputs that arecomprised of timed data sequences. Examples of such timed data sequencesinclude video, speech recognition, and handwriting—where processingrequires an analysis of data that changes temporally. In the presentinvention, where output data is in the form of operational parameters ofthe one or more near-infrared light sources 170, each of the one or moresensors 180, and each of the one or more stimulators 194, anunderstanding of the influence of various events on a state over aperiod of time lead to more highly accurate and reliable operationalparameters that may at least impact an amount of time that stimulationis provided.

Many other types of recurrent neural networks exist. These include, forexample, fully recurrent neural networks, Hopfield networks,bi-directional associative memory networks, echo state networks, neuralTuring machines, and many others, all of which exhibit the ability tomodel temporal dynamic behavior. Any instantiation of such neuralnetworks in the present invention may include one or more of thesetypes, and it is to be understood that neural networks applied withinthe machine learning-based framework may include different ones of suchtypes. Therefore, the present invention contemplates that many types ofneural networks may be implemented, depending at least on the type ofproblem being analyzed

Controller 200 reversibly connects to photobiomodulation therapy garment20 by operationally engaging terminal rail mount 164. Controller 200 mayoptionally include a rechargeable battery positioned within the housing.Controller 200 can be detached from terminal rail mount 164 for chargingthe rechargeable battery therein, by using a charging connector, such asUSB-C, micro-USB, or the like. Further, the charging connector canprovide wired data communication with a remote computer, such as a smartphone, laptop, desktop, or other computer device. In one or moreembodiments, this enables tracking of usage, and/or updating or changingoperational parameters such as desired dosimetry, duration, pulsedoperation, etc., and/or to update the controller firmware, and/or tochange the type of photobiomodulation therapy garment 20 to whichcontroller 200 will be attached. Controller 200 can be a universalcontroller, such that controller 200 can be connected to multipleembodiments of photobiomodulation therapy garment 20, such asphotobiomodulation therapy headband 22, a neck region garment, aposterior cervical region garment, a carpal region garment, an abdominalregion garment, and the like, each being configured to cover theirrespective regions when donned.

One or more near-infrared light sources 170 of photobiomodulation unit100 can be positioned into one or more separate near-infrared lightsource groupings arranged in a number of intergroup patterns relative toeach other and on the one or more regions of interest of skin region Sto be treated by the photobiomodulation therapy. For example, there canbe, e.g., one near-infrared light source grouping, two near-infraredlight source groupings, three near-infrared light source groupings, fournear-infrared light source groupings, five near-infrared light sourcegroupings, six near-infrared light source groupings, seven near-infraredlight source groupings, eight near-infrared light source groupings, ninenear-infrared light source groupings, or ten near-infrared light sourcegroupings. Each near-infrared light source groupings is spaced apartfrom the neighboring groupings, where the intergroup spacing can be thesame between each near-infrared light source grouping or can varyaccording to the desired dosimetry and vary according to the relativelocations of the desired regions of interest. The relative pattern ofnear-infrared light source groupings is configured to position eachgrouping on photobiomodulation therapy garment 20 to at least partiallycover their respective regions of interest on skin surface S, which mayappear to be a random pattern to the casual observer. The spacing of anintergroup pattern between each near-infrared light source grouping canbe defined by a column distance d1 and by a row distance d2. Theintergroup distance can be measured from the centers of the lightsources. In one or more embodiments, column distance d1 and row distanced2 are at least 5 mm, or at least 10 mm, or at least 15 mm, or at least20 mm, or at least 25 mm, or at least 30 mm, or at least 35 mm, or atleast 40 mm. In a rectangular array, row distance d2 can be the samedistance or differ from column distance d1.

In some embodiments, photobiomodulation unit 100 of photobiomodulationtherapy garment 20 comprise one or more near-infrared light sourcegroupings. Each of the one or more near-infrared light source groupingsare positioned in a pattern that is configured to direct each lightsource to a particular region of interest, when photobiomodulationtherapy garment 20 is correctly positioned atop forehead of person P. Insome embodiments, photobiomodulation unit 100 comprise one or morenear-infrared light source groupings positioned to so that whenphotobiomodulation therapy garment 20 is properly donned, each of theone or more near-infrared light source groupings is position in a mannerthat at least partially overlays or is substantially centered on aprimary acupuncture meridian, a major extraordinary vessel, a minorextraordinary vessel, or any combination thereof. A primary acupuncturemeridian includes, without limitation, a heart meridian, a pericardiummeridian, a lung meridian, a spleen meridian, a liver meridian, a kidneymeridian, a small intestine meridian, a large intestine meridian, atriple energizer meridian, a stomach meridian, a gallbladder meridian,and a bladder meridian. A major extraordinary vessel includes, withoutlimitation, a conception vessel and a governing vessel. A minorextraordinary vessel, a penetrating vessel, a girdling vessel, a yinlinking vessel, a yin motility vessel, a yang linking vessel, and a yangmotility vessel.

In some embodiments, and as shown in FIGS. 3, 9, 11, 12, 15, & 16,photobiomodulation unit 100 comprises six near-infrared light sourcegroupings, namely first near-infrared light source grouping 171, secondnear-infrared light source grouping 172, third near-infrared lightsource grouping 173, fourth near-infrared light source grouping 174,fifth near-infrared light source grouping 175, and sixth near-infraredlight source grouping 176. In some embodiments, and referring to FIGS.3, 15, 16, but also FIGS. 9 & 11, near-infrared light source groupings171, 172, 173, 174, 175, 176 of near-infrared light sources 170 presenton photobiomodulation unit 100 are arranged in a rectangular arraypattern, with three columns and two rows, with each near-infrared lightsource grouping separated by column distance d1 and row distance d2. Inthese embodiments, near-infrared light source groupings 171, 172, 173,174, 175, 176 are positioned in a pattern that is configured to directeach light source to a particular region of interest, whenphotobiomodulation therapy headband 22 is correctly positioned atopforehead of person P. For example, in some embodiments, near-infraredlight source groupings 171, 172, 173, 174, 175, 176 are configured intophotobiomodulation therapy headband 22 so that when donned atop foreheadof person P, photobiomodulation therapy headband 22 is substantiallypositioned above superciliary arch region 322 in a manner that positionsfirst, second, third, fourth, fifth and sixth near-infrared light sourcegroupings 171, 172, 173, 174, 175, 176 at least above eye sockets ofperson P. In some embodiments, each of near-infrared light sourcegroupings 171, 172, 173, 174, 175, 176 are positioned so that whenphotobiomodulation therapy headband 22 is properly donned, firstnear-infrared light source grouping 171 of near-infrared light source170 is located in a first position that at least partially overlays oris substantially centered on Fp1 site 300, second near-infrared lightsource grouping 172 of near-infrared light source 170 is located in asecond position that at least partially overlays or is substantiallycentered on Fpz site 302, third near-infrared light source grouping 173of near-infrared light source 170 is located in a third position that atleast partially overlays or is substantially centered on Fp2 site 304,fourth near-infrared light source grouping 174 of near-infrared lightsource 170 is located in a fourth position that at least partiallyoverlays or is substantially centered on F3 site 306, fifthnear-infrared light source grouping 175 of near-infrared light source170 is located in a fifth position that at least partially overlays oris substantially centered on Fz site 308, and sixth near-infrared lightsource grouping 176 of near-infrared light source 170 is located in asixth position that at least partially overlays or is substantiallycentered on F4 site 310.

In some embodiments, and as shown in FIG. 12, photobiomodulation unit100 comprises six near-infrared light source groupings of near-infraredlight source 170, namely first near-infrared light source grouping 171,second near-infrared light source grouping 172, third near-infraredlight source grouping 173, fourth near-infrared light source grouping174, fifth near-infrared light source grouping 175, and sixthnear-infrared light source grouping 176. The six near-infrared lightsource groupings are organized into two inverse triangles with first,second, third, and fourth near-infrared light source groupings 171, 172,173, 174 aligned in an upper row, and fifth and sixth near-infraredlight source groupings 175, 176 aligned in a lower row. First and secondnear-infrared light source groupings 171, 172 are positioned to cover aregion containing sites F3 306 and Fz 308 of head H and third and fourthlight groupings 173, 174 are positioned to cover a region containingsite Fz 308 and F4 310 of head H. Fifth near-infrared light sourcegrouping 175 is positioned to cover a region containing sites Fp1 300and sixth near-infrared light source grouping 176 is positioned to covera region containing sites Fp2 304. In these embodiments, one or moresensors 180 positioned in the lower row in between fifth and sixthnear-infrared light source groupings 175, 176.

In some embodiments, and as shown in FIG. 13, photobiomodulation unit100 comprises five near-infrared light source groupings of near-infraredlight source 170, namely first near-infrared light source grouping 171,second near-infrared light source grouping 172, third near-infraredlight source grouping 173, fourth near-infrared light source grouping174, and fifth near-infrared light source grouping 175. First, second,and third near-infrared light source groupings 171, 172, 173, arealigned in an upper row, and fourth and fifth near-infrared light sourcegroupings 174, 175 aligned in a lower row, with fourth near-infraredlight source grouping 174 located below first near-infrared light sourcegrouping 171 and fifth near-infrared light source grouping 175 locatedbelow third near-infrared light source grouping 173. First, second andthird near-infrared light source groupings 171, 172, 173 are positionedto cover a region containing sites F3 306, Fz 308 and F4 310 of head H.Fourth near-infrared light source grouping 174 is positioned to cover aregion containing sites Fp1 300 and fifth near-infrared light sourcegrouping 175 is positioned to cover a region containing sites Fp2 304.In these embodiments, one or more sensors 180 are located in the lowerrow and are positioned below second near-infrared light source grouping172 and in between fourth near-infrared light source grouping 174 andfifth near-infrared light source grouping 175.

In some embodiments, and as shown in FIG. 14, photobiomodulation unit100 comprises three near-infrared light source groupings ofnear-infrared light source 170, namely first near-infrared light sourcegrouping 171, second near-infrared light source grouping 172, and thirdnear-infrared light source grouping 173. First, second, and thirdnear-infrared light source groupings 171, 172, 173, are aligned in a rowand are positioned to cover a region containing sites F3 306, Fz 308 andF4 310 of head H. In these embodiments, one or more sensors 180 arepositioned below second near-infrared light source grouping 172.

In some embodiments, each of near-infrared light source groupingscomprises a single light near-infrared light source 170. For example,and as shown in FIGS. 11-14 & 16, each of near-infrared light sourcegroupings 171, 172, 173, 174, 175, 176 of photobiomodulation unit 100comprises a single light near-infrared light source 170. In embodimentswhere only a single light near-infrared light source 170 is present in anear-infrared light source grouping, such near-infrared light source 170is preferably a high-powered near-infrared light source having a radiantintensity (brightness) range of about 150 mW/sr or more, and morepreferably about 250 mW/sr or more.

In some embodiments, each of near-infrared light source groupingscomprises a plurality light near-infrared light sources 170. Forexample, and as shown in FIGS. 9 & 15, each of near-infrared lightsource groupings 171, 172, 173, 174, 175, 176 of photobiomodulation unit100 comprises nine light near-infrared light sources 170. In embodimentswhere a plurality light near-infrared light sources 170 is present in anear-infrared light source grouping, such near-infrared light source 170can all be low-powered near-infrared light source having a radiantintensity (brightness) range of 125 mW/sr or less. In other embodimentswhere a plurality light near-infrared light sources 170 is present in anear-infrared light source grouping, such near-infrared light source 170can all be a combination of both high-powered near-infrared light sourcehaving a radiant intensity (brightness) range of about 150 mW/sr ormore, and more preferably about 250 mW/sr or more and low-powerednear-infrared light source having a radiant intensity (brightness) rangeof 125 mW/sr or less.

Additionally, in embodiments where a near-infrared light source groupingcomprises a plurality light near-infrared light sources 170, there is anintragroup spacing between each individual near-infrared light source170 and the neighboring near-infrared light sources 170 within the samegroup. The intragroup spacing of each near-infrared light source 170 ofan a near-infrared light intragrouping can be the same between eachindividual near-infrared light source 170 or can vary according to thedesired dosimetry and vary according to the relative locations of thedesired regions of interest. In some embodiments, each individualnear-infrared light source 170 of each of near-infrared light sourcegrouping is arranged in a pattern configured for desired therapeuticeffect, with each individual near-infrared light source 170 beingrandomly relative to the other individual near-infrared light sources170 within the same near-infrared light source group, and/or in apattern determined by a combination of factors including a desiredtherapeutic effect, cost, manufacturing capabilities, and so on. Therelative pattern of near-infrared light source groupings is configuredto position each near-infrared light source 170 on photobiomodulationtherapy garment 20 to at least partially cover their respective regionsof interest on skin surface S, which may appear to be a random patternto the casual observer.

Each individual near-infrared light source 170 within a near-infraredlight intragrouping is spaced from all other individual near-infraredlight sources 170 within the same intragrouping by an intragroup lightsource spacing. Each near-infrared light source 170 in a near-infraredlight intragrouping can be arranged in a pattern that matches thelocation of multiple regions of interest on skin surface S. Thus, theresulting near-infrared light intragrouping can seemingly be arranged inirregular patterns that correspond to the location of multiple regionsof interest on skin surface S, where each can be simultaneously at leastpartially covered by a corresponding grouping. As a result, theintergroup spacing and relative positioning of each near-infrared lightsource 170 in a near-infrared light intragrouping can vary according tothe locations of the regions of interest on skin surface S.

In some embodiments, for example in a rectangular arrangement as shownin FIG. 3, the spacing between each near-infrared light source 170 of anear-infrared light intragrouping can be defined by a column spacing d3and by a row spacing d4. The intragroup spacing can be measured from thecenters of the near-infrared light source 170. In some embodiments,column spacing d3 and row spacing d4 are at least 2 mm, at least 3 mm,at least 4 mm, at least 5 mm, at least 6 mm, at least 7 mm, at least 8mm, at least 9 mm, at least 10 mm, at least 12 mm, or at least 15 mm. Ina rectangular array, row spacing d3 can be the same distance or differfrom column spacing d4. In such rectangular arrangement, eachnear-infrared light source 170 of a near-infrared light intragrouping isarranged in a n1×n2 array, where n1 and n2 each represent the number ofindividual near-infrared light sources 170 in a row and column,respectively. For example, an infrared light intragrouping can be a 2×2array, a 2×3 array, a 3×2 array, a 3×3 array, a 3×4 array, a 4×3 array,a 4×4 array, a 2×5 array, a 5×2 array, a 3×5 array, a 5×3 array, a 4×5array, a 5×4 array, a 5×5 array, and so on. In some embodiments, eachnear-infrared light source 170 of a near-infrared light intragroupingcan be configured as a radial or circular array about a single circle ormultiple concentric circles. In these embodiments, an intergroup spacingcan be measured from the centers of the light sources.

In some embodiments, each of near-infrared light source ofphotobiomodulation therapy garment 20 is configured as near-infraredlight intragrouping comprising a plurality of near-infrared lightsources 170 arranged in an intragroup array. In some embodiments,near-infrared light source groups 171, 172, 173, 174, 175, 176 ofphotobiomodulation therapy garment 20 are each configured asnear-infrared light intragrouping comprising a plurality ofnear-infrared light sources 170 arranged in an intragroup array, withfirst near-infrared light source group 171 comprising a plurality ofnear-infrared light sources 170 arranged in a first near-infrared lightintragrouping, second near-infrared light source group 172 comprising aplurality of near-infrared light sources 170 arranged in a secondnear-infrared light intragrouping, third near-infrared light sourcegroup 173 comprising a plurality of near-infrared light sources 170arranged in a third near-infrared light intragrouping, fourthnear-infrared light source group 174 comprising a plurality ofnear-infrared light sources 170 arranged in a fourth near-infrared lightintragrouping, fifth near-infrared light source group 175 comprising aplurality of near-infrared light sources 170 arranged in a fifthnear-infrared light intragrouping, and sixth near-infrared light sourcegroup 176 comprising a plurality of near-infrared light sources 170arranged in a sixth near-infrared light intragrouping.

In some embodiments, and referring to FIGS. 3, 9, & 12, near-infraredlight source groupings 171, 172, 173, 174, 175, 176 ofphotobiomodulation therapy headband 22 are each configured asnear-infrared light intragrouping comprising nine near-infrared lightsources 170 arranged in a 3×3 array of three columns and three rows. Inthis example, d3 is greater than d4, which can create therapeuticbenefits due to the combined and overlapping light patterns incident onskin surface S surface, as well as strategic gaps or areas of lesseroverlap of light patterns. In the illustrated example embodiment, d3=6mm to 7 mm and d4=9 mm to 10 mm. The overlapping pattern of incidentlight creates regions of varying power levels incident on skin surface Swithin and around each array or grouping, with areas of maximumirradiance and fluence immediately beneath each individual near-infraredlight source 170, areas of lesser irradiance and fluence between closelysituated individual near-infrared light sources 170, and areas of leastirradiance and fluence between individual near-infrared light sources170 situated furthest from one another. Additionally, although eachnear-infrared light intragrouping of near-infrared light sourcegroupings 171, 172, 173, 174, 175, 176 is each illustrated as having thesame intragroup pattern, each intragroup pattern can be configured withdiffering patterns and numbers of individual near-infrared light sources170, which can be determined based on the desired form of therapy andthe dosimetry required for each region of interest.

In one or more embodiments, in operation, groupings of near-infraredlight sources can all be activated by controller 200 using the sameoperational parameters (e.g., all groupings simultaneously activated,all in pulsed mode, and all with the same power settings). In one ormore embodiments, in operation, groupings of near-infrared light sourcescan each be activated by controller 200 with differing operationalparameters, where one or more selected groupings may be activated, whileother groupings remain off. Further, in one or more embodiments,controller 200 has capabilities to control the power level and/orpulsed/continuous operation for each grouping of near-infrared lightsources independent of other groupings of near-infrared light sources onphotobiomodulation therapy garment 20. There is a great deal offlexibility in operational parameters available. Not only can eachindividual grouping of near-infrared lights be individually operated,each individual near-infrared light source 170 in each grouping ofnear-infrared lights can be individually addressed and controlled usingindividual operating parameters. In this way, each individualnear-infrared light source 170 can be individually addressable as a unitsuch that each can activated/turned on or deactivated/turned offindependent of all other individual near-infrared light sources 170.Further, in one or more embodiments, each individual near-infrared lightsource 170 can be actuated in a pulsed or continuous mode independent ofall other individual near-infrared light sources 170. Additionally, inone or more embodiments, each individual near-infrared light source 170can be actuated using a power profile independent of all otherindividual light sources. In this way, a number of predefined patternscan be initiated via executable instructions from controller 200, wherethe patterns of activated light sources can change according to thedesired therapeutic effect and location of regions of interests.

Looking now at FIGS. 8, 15 & 16, in some embodiments, photobiomodulationtherapy garment 20 is assembled by sandwiching photobiomodulation unit100 between outer fabric sheet 40 and inner fabric sheet 70. In someembodiments, and as shown in FIG. 8, a hot melt adhesive film 210, sizedand shaped to cover a substantial portion or all of flexible printedcircuit board assembly 110, but not to cover terminal rail mount 164 ofconnection terminal 160, is positioned between outer fabric sheet 40 andphotobiomodulation unit 100. In some embodiments, and as shown in FIGS.15 & 16, liquid wire circuit assembly 150 is affixed directly to outerfabric sheet 40, e.g., by using an adhesive or weaving into outer fabricsheet 40. In embodiments where photobiomodulation unit 100 comprisesflexible printed circuit board assembly 110, photobiomodulation unit 100is aligned to outer fabric sheet 40 in a manner that allows terminalrail mount 164 of connection terminal 160 to be inserted throughterminal rail mount opening 58. In embodiments where photobiomodulationunit 100 comprises liquid wire circuit assembly 150, connection terminal160 is affixed to outer fabric sheet 40 during construction of liquidwire circuit assembly 150 onto outer fabric sheet 40.

Still referring to FIGS. 8, 15 & 16, once photobiomodulation unit 100 isposition on outer fabric sheet 40, a layer of double-sided tape 220,sized and shaped to cover a substantial portion or all ofphotobiomodulation unit 100, is positioned between photobiomodulationunit 100 and inner fabric sheet 70. Double-sided tape 220 includes oneor more near infrared light source openings 222 and one or more sensoropenings 224, each being cutouts configured to provide clearance fortheir respective components, such that double-sided tape 220 does notinterfere with the operation of the one or more near-infrared lightsources 170 and one or more sensors 180. If present, sensor cover 79 isproperly positioned over its corresponding sensor 180. Inner fabricsheet 70 is then aligned with outer fabric sheet 40 andphotobiomodulation unit 100 and positioned so that each of the one ormore near-infrared light sources 170 and each of the one or more sensors180 is properly positioned with their corresponding near infrared lightsource opening 76 and sensor opening 78 thereby permitting properfunctioning of these components. Inner fabric sheet 70 can then besecured to outer fabric sheet 40 by sewing the edges of inner fabricsheet 70 to outer fabric sheet 40.

A photobiomodulation therapy garment disclosed herein is useful inproviding a photobiomodulation therapy, including a transcranialphotobiomoculation therapy. Such non-invasive light-basedneuromodulation treatment requires no medication and provideslong-lasting benefits by changing how a user's brain works from theneuron-level up by providing a variety of positive photochemicalreactions. For example, a photobiomodulation therapy can increaseneuronal mitochondria energy and adenosine triphosphate (ATP) productionresulting in increased production of cellular energy. In addition,transfer of light energy can also trigger reactive oxygen species (ROS)production, which can regulate cellular and tissue-level inflammationand improve cellular repair and healing, and nitric oxide (NO)production which is critical for good blood vessel health and optimalblood flow, nutrient delivery and waste removal. This is important asinadequate cerebral blood flow and circulation can make the brainexperience fuzzy memory, forgetfulness, poor concentration and evendementia. Enhanced cellular energy and increased cerebral blood flowresult in increased neurogenesis and neuronal plasticity, increasedneuroprotection, enhanced neural repair, and reduced inflammation. Inaddition, such photobiomodulation therapy provides both calming andrelaxation benefits as well as improved focus and performance resultingin enhanced mental productivity, mental wellbeing and overall cognitivefunction.

In some embodiments, a photobiomodulation therapy garment disclosedherein is used as the sole therapeutic device. In some embodiments, aphotobiomodulation therapy garment disclosed herein is used inconjunction with another therapy. In some embodiments, aphotobiomodulation therapy garment disclosed herein is used inconjunction with another cognitive behavioral therapy.

In some embodiments, a photobiomodulation therapy garment disclosedherein is used in conjunction with another photobiomodulation therapy,such as, e.g., a high-power irradiance photobiomodulation therapy. Insome embodiments, an individual undergoes a high-power transcranialphotobiomodulation therapy using a stationary device capable ofadministering an irradiance of about 250 mW/cm² or more in conjunctionwith a low-power transcranial photobiomodulation therapy using aphotobiomodulation therapy garment disclosed herein capable ofadministering an irradiance of about 55 mW/cm² or less. In someembodiments, a high-power photobiomodulation therapy is conducted in ina clinical or other healthcare facility setting while a low-powerphotobiomodulation therapy is conducted in a non-clinical setting, suchas, e.g., at home, in a park, or when traveling in a vehicle. In someembodiments, a low-power transcranial photobiomodulation therapy is usedto augment the effectiveness of a high-power transcranialphotobiomodulation therapy and improve the treatment depression anddepressive symptoms in the individual. In some embodiments, acircadian-based timing administration disclosed herein would be used totime the administration of a high-power transcranial photobiomodulationtherapy, a low-power transcranial photobiomodulation therapy, or both.

In some embodiments, a photobiomodulation therapy garment disclosedherein is used in conjunction with transcranial magnetic stimulation(TMS). In some embodiments, an individual undergoes a TMS in conjunctionwith a low-power transcranial photobiomodulation therapy using aphotobiomodulation therapy garment disclosed herein capable ofadministering an irradiance of about 20 mW/cm² to about 500 mW/cm². Insome embodiments, a TMS is conducted in a clinical or other healthcarefacility setting while a low-power photobiomodulation therapy isconducted in a non-clinical setting, such as, e.g., at home, in a park,or when traveling in a vehicle. In some embodiments, a low-powertranscranial photobiomodulation therapy is used to augment theeffectiveness of a TMS and improve the treatment depression anddepressive symptoms in the individual. In some embodiments, acircadian-based timing administration disclosed herein would be used totime the administration of a TMS, a low-power transcranialphotobiomodulation therapy, or both.

In some embodiments, a photobiomodulation therapy garment disclosedherein is used in conjunction with an evidence-based mental healthpractice. In some embodiments, an individual undergoes an evidence-basedmental health practice in conjunction with a low-power transcranialphotobiomodulation therapy using a photobiomodulation therapy garmentdisclosed herein capable of administering an irradiance of about 55mW/cm² or less. An evidence-based mental health practice includes,without limitation, Evidence Based Psychotherapy (EBT), CognitiveBehavioral Therapy (CBT), Dialectical Behavioral Therapy (DBT), ExposureTherapy, Functional Family Therapy (FFT), Assertive Community Treatment(ACT), Acceptance and Commitment Therapy (ACT), Prolonged ExposureTherapy (PE), Cognitive Training and Rehab, and MotivationalInterviewing (MI). In some embodiments, an evidence-based mental healthpractice is conducted by a therapist in a clinical or other healthcarefacility setting while the low-power photobiomodulation therapy isconducted in a non-clinical setting, such as, e.g., at home, in a park,or when traveling in a vehicle. In some embodiments, an evidence-basedmental health practice is conducted by a therapist in a virtual settingwhile the low-power photobiomodulation therapy is conducted in anon-clinical setting, such as, e.g., at home, in a park, or whentraveling in a vehicle. In some embodiments, an evidence-based mentalhealth practice is a digital-based Artificial Intelligence (AI) therapywhile the low-power photobiomodulation therapy is conducted in anon-clinical setting, such as, e.g., at home, in a park, or whentraveling in a vehicle. In some embodiments, a low-power transcranialphotobiomodulation therapy is used to augment the effectiveness of anevidence-based mental health practice and improve the treatmentdepression and depressive symptoms in the individual. In someembodiments, a circadian-based timing administration disclosed hereinwould be used to time the administration of an evidence-based mentalhealth practice, a low-power transcranial photobiomodulation therapy, orboth.

In some embodiments, a photobiomodulation therapy garment disclosedherein is used in conjunction with an ocular light therapy, such as,e.g., a bright light therapy or blue light therapy. In some embodiments,an individual undergoes an ocular light therapy in conjunction with atranscranial photobiomodulation therapy using a photobiomodulationtherapy garment disclosed herein capable of administering an irradianceof about 20 mW/cm² to about 500 mW/cm². In some embodiments, atranscranial photobiomodulation therapy can be administered on a dailybasis during an ocular light therapy and/or between each of two or moreocular light therapies. In some embodiments, the transcranialphotobiomodulation therapy is used to augment the effectiveness of anocular light therapy by enhancing relaxation, calmness, and well-being.In some embodiments, a circadian-based timing administration disclosedherein would be used to time the administration of an ocular lighttherapy, a transcranial photobiomodulation therapy, or both.

In some embodiments, a photobiomodulation therapy garment disclosedherein is used in conjunction with a mindfulness therapy. In someembodiments, an individual practices a mindfulness therapy inconjunction with a transcranial photobiomodulation therapy using aphotobiomodulation therapy garment disclosed herein capable ofadministering an irradiance of about 20 mW/cm² to about 300 mW/cm². Insome embodiments, a transcranial photobiomodulation therapy can beadministered on a daily basis during a mindfulness therapy and/orbetween each of two or more mindfulness therapies. In some embodiments,a transcranial photobiomodulation therapy is used to augment theeffectiveness of a mindfulness therapy by enhancing relaxation,calmness, and well-being. In some embodiments, a circadian-based timingadministration disclosed herein would be used to time the administrationof a mindfulness therapy, a transcranial photobiomodulation therapy, orboth.

In some embodiments, a photobiomodulation therapy garment disclosedherein is used in conjunction with a meditative therapy. In someembodiments, an individual practices a meditative therapy in conjunctionwith a transcranial photobiomodulation therapy using aphotobiomodulation therapy garment disclosed herein capable ofadministering an irradiance of about 20 mW/cm² to about 300 mW/cm². Insome embodiments, a transcranial photobiomodulation therapy can beadministered on a daily basis during a meditative therapy and/or betweeneach of two or more meditative therapies. In some embodiments, atranscranial photobiomodulation therapy is used to augment theeffectiveness of a meditative therapy by enhancing relaxation, calmness,and well-being. In some embodiments, a circadian-based timingadministration disclosed herein would be used to time the administrationof a meditative therapy, a transcranial photobiomodulation therapy, orboth.

In some embodiments, a photobiomodulation therapy using aphotobiomodulation therapy garment disclosed herein, whether alone or inconjunction with another therapy, is administered based on a circadianrhythm of an individual. In some embodiments, an individual undergoes atranscranial photobiomodulation therapy using a photobiomodulationtherapy garment disclosed herein in the morning hours, such as, e.g.,between 6:00 am and 10:00 am. In some embodiments, an individualundergoes a transcranial photobiomodulation therapy using aphotobiomodulation therapy garment disclosed herein in theafternoon/early evening hours, such as, e.g., between 3:00 pm and 7:00pm. A photobiomodulation therapy garment disclosed herein capable ofadministering an irradiance of about 20 mW/cm² to about 500 mW/cm² wouldbe used in such a circadian-based timing administration. In someembodiments, a circadian-based timing administration would be useful forthe treatment depression and depressive symptoms in the individual.

Aspects of the present specification may also be described by thefollowing embodiments:

-   1. A photobiomodulation therapy garment worn atop a skin surface    having a region of interest, the photobiomodulation therapy garment    comprising a flexible outer sheet; a flexible inner sheet having a    portion to permit passage of near-infrared light therethrough, the    inner sheet being configured to face the skin surface; a flexible    circuit board positioned between the outer sheet and the inner    sheet; a near-infrared light source mounted on the flexible circuit    board and aligned with the portion of the flexible inner sheet, the    near-infrared light source configured to emit near-infrared light at    a wavelength between 600 nm to 1600 nm and at a predetermined    dosimetry directed at the region of interest on the skin surface    during a photobiomodulation treatment; and a controller having a    processor and a memory, the controller being in electrical    communication with the near-infrared light source through the    flexible circuit board, the processor and the memory configured with    executable instructions for controlling one or more of a light    source operation time, a light source fluence level, a light source    irradiance level, a light source pulsed operation, and a light    source continuous operation.-   2. The photobiomodulation therapy garment of embodiment 1 wherein    the near-infrared light source is part of a grouping of    near-infrared light sources arranged on the flexible circuit board    and configured to be directed at the region of interest on the skin    surface during the photobiomodulation treatment.-   3. The photobiomodulation therapy garment of embodiments 1 or 2    wherein the grouping of near-infrared light sources are arranged    with an intragroup light source spacing of at least 2 mm    therebetween, or at least 3 mm therebetween, or at least 4 mm    therebetween, or at least 5 mm therebetween, or at least 6 mm    therebetween, or at least 7 mm therebetween, or at least 8 mm    therebetween, or at least 9 mm therebetween, or at least 10 mm    therebetween.-   4. The photobiomodulation therapy garment of any one of embodiments    1-3 wherein the region of interest is one of an Fp1 site, an Fpz    site, an Fp2 site, an F3 site, an Fz site, and an F4 site, a    posterior cervical site, a carpal site, and an abdominal site, the    grouping of the near-infrared light sources is configured to at    least partially overlay the region of interest.-   5. The photobiomodulation therapy garment of any one of embodiments    1-4 wherein a sensor is configured to detect one or more parameters    indicative of a position and thereafter transmit a position signal    to the controller so that the position on the skin surface can be    determined.-   6. The photobiomodulation therapy garment of any one of embodiments    1-5 wherein the grouping of near-infrared light sources is    configured to at least partially overlay an Fp1 site, a second    grouping of near-infrared light sources is configured to at least    partially overlay an Fpz site, a third grouping of near-infrared    light sources is configured to at least partially overlay an Fp2    site, a fourth grouping of near-infrared light sources is configured    to at least partially overlay an F3 site, a fifth grouping of    near-infrared light sources is configured to at least partially    overlay an Fz site, a sixth grouping of near-infrared light sources    is configured to at least partially overlay an F4 site.-   7. The photobiomodulation therapy garment of any one of embodiments    1-6 wherein a sensor is configured to detect one or more parameters    indicative of a position and thereafter transmit a position signal    to the controller so that the position on the skin surface can be    determined, the sensor is positioned between the second grouping of    near-infrared light sources and the fifth grouping of near-infrared    light sources.-   8. The photobiomodulation therapy garment of any one of embodiments    1-7 wherein each of the grouping of near-infrared light sources, the    second grouping of near-infrared light sources, the third grouping    of near-infrared light sources, the fourth grouping of near-infrared    light sources, the fifth grouping of near-infrared light sources,    and the sixth grouping of near-infrared light sources are minimally    separated from one another by an intergroup light source spacing    that is greater than 5 mm, or that is greater than 10 mm, or that is    greater than 15 mm, or that is greater than 20 mm, or that is    greater than 25 mm, or that is greater than 30 mm.-   9. The photobiomodulation therapy garment of any one of embodiments    1-8 wherein the grouping of near-infrared light sources is arranged    in a first 3×3 array.-   10. The photobiomodulation therapy garment of any one of embodiments    1-9 further comprising a second grouping of near-infrared light    sources arranged in a second 3×3 array, a third grouping of    near-infrared light sources arranged in a third 3×3 array, a fourth    grouping of near-infrared light sources arranged in a fourth 3×3    array, a fifth grouping of near-infrared light sources arranged in a    fifth 3×3 array, and a sixth grouping of near-infrared light sources    arranged in a sixth 3×3 array.-   11. The photobiomodulation therapy garment of any one of embodiments    1-10 wherein each of the first 3×3 array, the second 3×3 array, the    third 3×3 array, the fourth 3×3 array, the fifth 3×3 array, and the    sixth 3×3 array are minimally separated from one another by an    intergroup light source spacing that is greater than 5 mm, or that    is greater than 10 mm, or that is greater than 15 mm, or that is    greater than 20 mm, or that is greater than 25 mm, or that is    greater than 30 mm.-   12. The photobiomodulation therapy garment of any one of embodiments    1-11 wherein each of the first 3×3 array, the second 3×3 array, the    third 3×3 array, the fourth 3×3 array, the fifth 3×3 array, and the    sixth 3×3 array are minimally separated from one another by an    intergroup light source spacing sufficient to prevent substantial    light bleed therebetween.-   13. The photobiomodulation therapy garment of any one of embodiments    1-12 wherein the region of interest is one or more of an Fp1 site,    an Fpz site, an Fp2 site, an F3 site, an Fz site, an F4 site, a    posterior cervical site, a carpal site, and an abdominal site on the    skin surface.-   14. The photobiomodulation therapy garment of any one of embodiments    1-13 wherein the near-infrared light source is configured to emit    near-infrared light directed to an Fp1 site, a second near-infrared    light source is configured to emit near-infrared light directed to    an Fpz site, third near-infrared light source is configured to emit    near-infrared light directed to an Fp2 site, a fourth near-infrared    light source is configured to emit near-infrared light directed to    an F3 site, a fifth near-infrared light source is configured to emit    near-infrared light directed to an Fz site, a sixth near-infrared    light source is configured to emit near-infrared light directed to    an F4 site, wherein the Fp1 site is the region of interest, the Fpz    site is a second region of interest, the Fp2 site is a third region    of interest, the F3 site is a fourth region of interest, the Fz site    is a fifth region of interest, and the F4 site is a sixth region of    interest.-   15. The photobiomodulation therapy garment of any one of embodiments    1-14 wherein a sensor is configured to detect one or more parameters    indicative of a position and thereafter transmit a position signal    to the controller so that the position can be determined on the skin    surface, wherein the sensor is positioned between the second    near-infrared light source array and the fifth near-infrared light    source.-   16. The photobiomodulation therapy garment of any one of embodiments    1-15 wherein the sensor is one or both of a heart rate sensor and a    temperature sensor.-   17. The photobiomodulation therapy garment of any one of embodiments    1-16 wherein each of the near-infrared light source, the second    near-infrared light source, the third near-infrared light source,    the fourth near-infrared light source, the fifth near-infrared light    source, and the sixth near-infrared light source are separated from    one another by a light source spacing that is greater than 5 mm, or    that is greater than 10 mm, or that is greater than 15 mm, or that    is greater than 20 mm, or that is greater than 25 mm, or that is    greater than 30 mm.-   18. The photobiomodulation therapy garment of any one of embodiments    1-9 wherein the near-infrared light source is a first grouping of    near-infrared light sources, the second near-infrared light source    is a second grouping of near-infrared light sources, the third    near-infrared light source is a third grouping of near-infrared    light sources, the fourth near-infrared light source is a fourth    grouping of near-infrared light sources, the fifth near-infrared    light source is a fifth grouping of near-infrared light sources, and    the sixth near-infrared light source is a sixth grouping of    near-infrared light sources.-   19. The photobiomodulation therapy garment of any one of embodiments    1-18 wherein the grouping of near-infrared light sources is arranged    in a first 3×3 array, the second grouping of near-infrared light    sources is arranged in a second 3×3 array, the third grouping of    near-infrared light sources is arranged in a third 3×3 array, the    fourth grouping of near-infrared light sources is arranged in a    fourth 3×3 array, the fifth grouping of near-infrared light sources    is arranged in a fifth 3×3 array, and the sixth grouping of    near-infrared light sources is arranged in a sixth 3×3 array.-   20. The photobiomodulation therapy garment of any one of embodiments    1-19 wherein each of the first 3×3 array, the second 3×3 array, the    third 3×3 array, the fourth 3×3 array, the fifth 3×3 array, and the    sixth 3×3 array are minimally separated from one another by an    intergroup light source spacing that is greater than 5 mm, or that    is greater than 10 mm, or that is greater than 15 mm, or that is    greater than 20 mm, or that is greater than 25 mm, or that is    greater than 30 mm.-   21. The photobiomodulation therapy garment of any one of embodiments    1-20 wherein each of the first 3×3 array, the second 3×3 array, the    third 3×3 array, the fourth 3×3 array, the fifth 3×3 array, and the    sixth 3×3 array are separated from one another by an intergroup    light source spacing sufficient to prevent substantial light bleed    therebetween.-   22. The photobiomodulation therapy garment of any one of embodiments    1-21 further comprising one or more stimulators.-   23. The photobiomodulation therapy garment of embodiment 22, wherein    the one or more stimulators include a component that can generate a    magnetic field.-   24. A photobiomodulation therapy garment comprising a garment    structure configured to be donned by a user atop a skin surface; a    first near-infrared light source integrated with the garment    structure; a second near-infrared light source integrated with the    garment structure and spaced apart from the first near-infrared    light source, the first near-infrared light source and the second    near-infrared light source configured to emit near-infrared light at    a wavelength between 600 nm to 1600 nm and at a predetermined    dosimetry, the first near-infrared light source configured to be    directed toward a first region of interest on the skin surface and    the second near-infrared light source configured to be directed    toward a second region of interest on the skin surface when donned    during a photobiomodulation treatment; and a controller having a    processor and a memory, the controller being in electrical    communication with the first near-infrared light source and the    second near-infrared light source, and configured with executable    instructions for independently controlling the operation of each of    the first near-infrared light source and the second near-infrared    light source.-   25. The photobiomodulation therapy garment of embodiment 24 wherein    the executable instructions are configured for controlling one or    more of a light source operation time, a light source fluence level,    a light source irradiance level, a light source pulsed operation,    and a light source continuous operation.-   26. The photobiomodulation therapy garment of embodiments 24 or 25    wherein a sensor is integrated with the garment structure and    configured to detect one or more parameters indicative of a    reference position on the skin surface, such that when the sensor is    positioned atop a reference position on the skin surface the first    near-infrared light source will be positioned atop the first region    of interest of the skin surface and the second near-infrared light    source will be positioned atop the second region of interest of the    skin surface.-   27. The photobiomodulation therapy garment of any one of embodiments    24-26 wherein the sensor is one or both of a heart rate sensor and a    temperature sensor.-   28. The photobiomodulation therapy garment of any one of embodiments    24-27 wherein the first near-infrared light source is part of a    first grouping of near-infrared light sources and the second    near-infrared light source is part of a second grouping of    near-infrared light sources.-   29. The photobiomodulation therapy garment of any one of embodiments    24-28 wherein each of the first grouping of near-infrared light    sources and the second grouping of near-infrared light sources are    arranged with an intragroup light source spacing of at least 2 mm    therebetween, or at least 3 mm therebetween, or at least 4 mm    therebetween, or at least 5 mm therebetween, or at least 6 mm    therebetween, or at least 7 mm therebetween, or at least 8 mm    therebetween, or at least 9 mm therebetween, or at least 10 mm    therebetween.-   30. The photobiomodulation therapy garment of any one of embodiments    24-29 wherein the first grouping of near-infrared light sources and    the second grouping of near-infrared light sources are minimally    separated from one another by an intergroup light source spacing    that is greater than 5 mm, or that is greater than 10 mm, or that is    greater than 15 mm, or that is greater than 20 mm, or that is    greater than 25 mm, or that is greater than 30 mm.-   31. The photobiomodulation therapy garment of any one of embodiments    24-30 wherein the first grouping of near-infrared light sources is    arranged in a first 3×3 array and the second grouping of    near-infrared light sources is arranged in a second 3×3 array.-   32. The photobiomodulation therapy garment of any one of embodiments    24-31 further comprising a third grouping of near-infrared light    sources arranged in a third 3×3 array, a fourth grouping of    near-infrared light sources arranged in a fourth 3×3 array, a fifth    grouping of near-infrared light sources arranged in a fifth 3×3    array, and a sixth grouping of near-infrared light sources arranged    in a sixth 3×3 array.-   33. The photobiomodulation therapy garment of any one of embodiments    24-32 wherein a Fp1 site is the first region of interest, a Fpz site    is the second region of interest, a Fp2 site is a third region of    interest, a F3 site is a fourth region of interest, a Fz site is a    fifth region of interest, and a F4 site is a sixth region of    interest; and the first 3×3 array is configured to emit    near-infrared light directed to the Fp1 site, the second 3×3 array    is configured to emit near-infrared light directed to the Fpz site,    the third 3×3 array is configured to emit near-infrared light    directed to the Fp2 site, the fourth 3×3 array is configured to emit    near-infrared light directed to the F3 site, the fifth 3×3 array is    configured to emit near-infrared light directed to the Fz site, the    sixth 3×3 array is configured to emit near-infrared light directed    to the F4 site.-   34. The photobiomodulation therapy garment of any one of embodiments    24-33 wherein the first region of interest is one of an Fp1 site, an    Fpz site, an Fp2 site, an F3 site, an Fz site, and an F4 site, a    posterior cervical site, a carpal site, and an abdominal site.-   35. The photobiomodulation therapy garment of any one of embodiments    24-34 wherein the second region of interest is one of an Fp1 site,    an Fpz site, an Fp2 site, an F3 site, an Fz site, and an F4 site, a    posterior cervical site, a carpal site, and an abdominal site.-   36. The photobiomodulation therapy garment of any one of embodiments    24-35 further comprising a third near-infrared light source, a    fourth near-infrared light source, a fifth near-infrared light    source, and a sixth near-infrared light source.-   37. The photobiomodulation therapy garment of any one of embodiments    24-36 wherein a Fp1 site is the first region of interest, a Fpz site    is the second region of interest, a Fp2 site is a third region of    interest, a F3 site is a fourth region of interest, a Fz site is a    fifth region of interest, and a F4 site is a sixth region of    interest; and the first near-infrared light source is configured to    emit near-infrared light directed to the Fp1 site, the second    near-infrared light source is configured to emit near-infrared light    directed to the Fpz site, the third near-infrared light source is    configured to emit near-infrared light directed to the Fp2 site, the    fourth near-infrared light source is configured to emit    near-infrared light directed to the F3 site, the fifth near-infrared    light source is configured to emit near-infrared light directed to    the Fz site, the sixth near-infrared light source is configured to    emit near-infrared light directed to the F4 site.-   38. The photobiomodulation therapy garment of any one of embodiments    24-37 further comprising one or more stimulators.-   39. The photobiomodulation therapy garment of embodiment 38, wherein    the one or more stimulators include a component that can generate a    magnetic field.

Aspects of the present specification may also be described by thefollowing embodiments:

-   1. A photobiomodulation therapy garment comprising: a garment    configured to be donned by a user atop a skin surface, the garment    comprising a first surface and a second surface opposite the first    surface, the first surface being configured to face the skin surface    once the garment is donned, and a photobiomodulation unit integrated    within the garment, the photobiomodulation unit comprising a    connection terminal, one or more near-infrared light sources, and    one or more sensors, the connection terminal in electronic    communication with the one or more near-infrared light sources and    one or more sensors, wherein the one or more near-infrared light    sources are each configured to emit near-infrared light at a    wavelength between 600 nm to 1600 nm and at a predetermined    dosimetry, a controller, the controller including a processor and a    memory, the controller configured to operationally engage a terminal    rail of the connection terminal in an manner that establishes    electronic communication between the controller and the connection    terminal; wherein the first surface of the garment includes a first    portion comprising one or more light openings, with each of the one    or more near-infrared light sources being in operational alignment    with the one or more light openings to permit proper passage of    near-infrared light from the one or more near-infrared light sources    therethrough, wherein the first surface of the garment includes a    second portion comprising one or more sensor openings with each of    the one or more sensors being in operational alignment with the one    or more sensor openings to permit proper functionality of the one or    more sensors therethrough, and wherein the processor and the memory    configured with executable instructions for independently    controlling each of the one or more near-infrared light sources and    each of each of the one or more sensors.-   2. The photobiomodulation therapy garment of embodiment 1, wherein    the garment is configured to wrap about or conform to a body part    region, with the capability to be moved from one body part region to    another body part region on the body.-   3. The photobiomodulation therapy garment of embodiment 2, wherein    the body part region is a head region, a neck region, a shoulder    region, a torso region, a hand region, a wrist region, an arm    region, a foot region, or a leg region, or any combination thereof.-   4. The photobiomodulation therapy garment of embodiment 2, wherein    the garment is a band, a wrap, a scarf, a shawl, a cloak, a robe, or    a blanket.-   5. The photobiomodulation therapy garment of embodiment 1, wherein    the garment is sized and dimensioned to specifically fit a    particular body part.-   6. The photobiomodulation therapy garment of embodiment 5, wherein    the particular body part is a head region, a neck region, a shoulder    region, a torso region, a hand region, a wrist region, an arm    region, a foot region, or a leg region, or any combination thereof.-   7. The photobiomodulation therapy garment of embodiment 4, wherein    the garment is a hat, a visor, a shirt, a pants, a sock, a glove, or    an undergarment.-   8. The photobiomodulation therapy garment of any one of embodiments    1-7, wherein each of the one or more near-infrared light sources is    a near-infrared light emitting diode.-   9. The photobiomodulation therapy garment of any one of embodiments    1-8, wherein each of the one or more sensors is configured to detect    and collect information on one or more parameters of the garment,    the photobiomodulation unit and components therein, the controller    and components therein, and the user, and thereafter transmit the    information to the controller.-   10. The photobiomodulation therapy garment of embodiment 9, wherein    the one or more parameters includes operational information of the    garment, the photobiomodulation unit and components therein, and the    controller and components therein, biometric information on the    user, or any combination thereof.-   11. The photobiomodulation therapy garment of any one of embodiments    1-10, wherein the executable instructions independently control each    of the one or more near-infrared light sources.-   12. The photobiomodulation therapy garment of embodiment 11, wherein    the executable instructions control activation, duration of    activation, deactivation, duration of deactivation, a pattern and    timing of activation, a pattern and timing of deactivation, a    fluence level, an irradiance level, a dosimetry level, a pulsed    operation, a continuous operation, an operation time, a cycle    duration, or any combination thereof for each of the one or more    near-infrared light sources.-   13. The photobiomodulation therapy garment of any one of embodiments    1-12, wherein the executable instructions independently control each    of the one or more sensors.-   14. The photobiomodulation therapy garment of embodiment 13, wherein    the executable instructions control collection and analysis of the    information of each of the one or more sensors.-   15. The photobiomodulation therapy garment of any one of embodiments    1-14, wherein the one or more near-infrared light sources are a    plurality of spaced apart near-infrared light sources.-   16. The photobiomodulation therapy garment of embodiment 15, wherein    the plurality of spaced apart near-infrared light source is between    3 and 6 near-infrared light sources.-   17. The photobiomodulation therapy garment of embodiment 15 or 16,    wherein the plurality of spaced apart near-infrared light sources is    arranged in a single row.-   18. The photobiomodulation therapy garment of embodiment 15 or 16,    wherein the plurality of spaced apart near-infrared light sources is    arranged in a plurality of rows.-   19. The photobiomodulation therapy garment of embodiment 18, wherein    the plurality of rows is between 2 and 6.-   20. The photobiomodulation therapy garment of any one of embodiments    15-19, wherein the plurality of spaced apart near-infrared light    sources is arranged in a plurality of columns.-   21. The photobiomodulation therapy garment of embodiment 20, wherein    the plurality of columns is between 2 and 8.-   22. The photobiomodulation therapy garment of any one of embodiments    15-17, 20, or 21, wherein the plurality of near-infrared light    sources are arranged in a 1×2 array, a 1×3 array, a 1×4 array, a 1×5    array, a 1×6 array, a 1×7 array, a 1×8 array of row to columns.-   23. The photobiomodulation therapy garment of any one of embodiments    15-17, 20, or 21, wherein the plurality of near-infrared light    sources comprise three near-infrared light sources arranged in a 1×3    array of row to columns.-   24. The photobiomodulation therapy garment of any one of embodiments    17, or 20-23, wherein spacing between each of the plurality of    near-infrared light sources contained in the single row is between    0.5 cm to 4 cm and the spacing between each of the plurality of    near-infrared light sources contained in each of the plurality of    columns is between 0.5 cm to 4 cm.-   25. The photobiomodulation therapy garment of any one of embodiments    15, 16, 18-21, wherein the plurality of near-infrared light sources    are arranged in a 2×2 array, a 2×3 array, a 2×4 array, a 2×5 array,    a 2×6 array, a 2×7 array, a 2×8 array, 3×2 array, a 3×3 array, a 3×4    array, a 3×5 array, a 3×6 array, a 3×7 array, or a 3×8 array of rows    to columns.-   26. The photobiomodulation therapy garment of any one of embodiments    15, 16, 18-21, wherein the plurality of near-infrared light sources    comprise six near-infrared light sources arranged in a 2×3 array of    rows to columns.-   27. The photobiomodulation therapy garment of any one of embodiments    15, 16, 18-21, wherein the plurality of near-infrared light sources    comprise six near-infrared light sources arranged with four    near-infrared light sources located in a top row and two    near-infrared light sources located in a bottom row.-   28. The photobiomodulation therapy garment of any one of embodiments    18-21, or 25-27, wherein spacing between each of the plurality of    near-infrared light sources contained in each of the plurality of    rows is between 0.5 cm to 4 cm and the spacing between each of the    plurality of near-infrared light sources contained in each of the    plurality of columns is between 0.5 cm to 4 cm.-   29. The photobiomodulation therapy garment of any one of embodiments    15-28, wherein the plurality of near-infrared light sources are    arranged in a plurality of spaced apart near-infrared light source    groups, each of the plurality of near-infrared light source groups    comprising a plurality of near-infrared light sources.-   30. The photobiomodulation therapy garment of embodiment 29, wherein    the plurality of spaced apart near-infrared light source groups is    arranged in a single row.-   31. The photobiomodulation therapy garment of embodiment 29, wherein    the plurality of spaced apart near-infrared light source groups is    arranged in a plurality of rows.-   32. The photobiomodulation therapy garment of embodiment 31, wherein    the plurality of rows is between 2 and 6.-   33. The photobiomodulation therapy garment of any one of embodiments    29-32, wherein the plurality of spaced apart near-infrared light    source groups is arranged in a plurality of columns.-   34. The photobiomodulation therapy garment of embodiment 33, wherein    the plurality of columns is between 2 and 8.-   35. The photobiomodulation therapy garment of any one of embodiments    29, 30, 33, or 34, wherein the plurality of near-infrared light    source groups are arranged in a 1×2 array, a 1×3 array, a 1×4 array,    a 1×5 array, a 1×6 array, a 1×7 array, a 1×8 array of row to    columns.-   36. The photobiomodulation therapy garment of any one of embodiments    30, or 33-35, wherein spacing between each of the plurality of    near-infrared light source groups contained in the single row is    between 0.5 cm to 4 cm and the spacing between each of the plurality    of near-infrared light source groups contained in each of the    plurality of columns is between 0.5 cm to 4 cm.-   37. The photobiomodulation therapy garment of any one of embodiments    29, 31-34, wherein the plurality of near-infrared light source    groups are arranged in a 2×2 array, a 2×3 array, a 2×4 array, a 2×5    array, a 2×6 array, a 2×7 array, a 2×8 array, 3×2 array, a 3×3    array, a 3×4 array, a 3×5 array, a 3×6 array, a 3×7 array, or a 3×8    array of rows to columns.-   38. The photobiomodulation therapy garment of any one of embodiments    31-34, or 37, wherein spacing between each of the plurality of    near-infrared light source groups contained in each of the plurality    of rows is between 0.5 cm to 4 cm and the spacing between each of    the plurality of near-infrared light source groups contained in each    of the plurality of columns is between 0.5 cm to 4 cm.-   39. The photobiomodulation therapy garment of any one of embodiments    29-38, wherein the plurality of spaced apart near-infrared light    sources is arranged in a single row.-   40. The photobiomodulation therapy garment of any one of embodiments    29-38, wherein the plurality of spaced apart near-infrared light    sources is arranged in a plurality of rows.-   41. The photobiomodulation therapy garment of embodiment 40, wherein    the plurality of rows is between 2 and 6.-   42. The photobiomodulation therapy garment of any one of embodiments    39-41, wherein the plurality of spaced apart near-infrared light    sources is arranged in a plurality of columns.-   43. The photobiomodulation therapy garment of embodiment 42, wherein    the plurality of columns is between 2 and 8.-   44. The photobiomodulation therapy garment of any one of embodiments    39, 42, or 43, wherein the plurality of near-infrared light sources    are arranged in a 1×2 array, a 1×3 array, a 1×4 array, a 1×5 array,    a 1×6 array, a 1×7 array, a 1×8 array of row to columns.-   45. The photobiomodulation therapy garment of any one of embodiments    39, or 42-44, wherein spacing between each of the plurality of    near-infrared light sources contained in the single row is between 1    mm to 4 mm and the spacing between each of the plurality of    near-infrared light sources contained in each of the plurality of    columns is between 1 mm to 4 mm.-   46. The photobiomodulation therapy garment of any one of embodiments    40-43, wherein the plurality of near-infrared light sources are    arranged in a 2×2 array, a 2×3 array, a 2×4 array, a 2×5 array, a    2×6 array, a 2×7 array, a 2×8 array, 3×2 array, a 3×3 array, a 3×4    array, a 3×5 array, a 3×6 array, a 3×7 array, or a 3×8 array of rows    to columns.-   47. The photobiomodulation therapy garment of any one of embodiments    40-43, wherein the plurality of near-infrared light sources comprise    nine near-infrared light sources arranged in a 3×3 array of rows to    columns.-   48. The photobiomodulation therapy garment of any one of embodiments    40-43, 46, or 47, wherein spacing between each of the plurality of    near-infrared light sources contained in each of the plurality of    rows is between 1 mm to 4 mm and the spacing between each of the    plurality of near-infrared light sources contained in each of the    plurality of columns is between 1 mm to 4 mm.-   49. The photobiomodulation therapy garment of any one of embodiments    1-48 further comprising one or more stimulators.-   50. The photobiomodulation therapy garment of embodiment 49, wherein    the one or more stimulators include a component that can generate a    magnetic field.-   51. The photobiomodulation therapy garment of any one of embodiments    1-50, wherein the skin surface comprises a forehead site, a    posterior cervical site, a carpal site, an abdominal site, or any    combination thereof.-   52. The photobiomodulation therapy garment of embodiment 51, wherein    the forehead site comprises a dorsolateral prefrontal cortex region,    a frontal eye fields region, or both.-   53. The photobiomodulation therapy garment of embodiment 51, wherein    the forehead site comprises an Fp1 site, an Fpz site, an Fp2 site,    an F3 site, an Fz site, an F4 site, or any combination thereof.

EXAMPLES

The following non-limiting examples are provided for illustrativepurposes only in order to facilitate a more complete understanding ofrepresentative embodiments now contemplated. These examples should notbe construed to limit any of the embodiments described in the presentspecification, including those pertaining to a photobiomodulationtherapy garment, or methods and uses disclosed herein.

Example 1 Photobiomodulation Therapy Garment

In one example arrangement of transcranial photobiomodulation therapygarment 20, specifically photobiomodulation therapy headband 22, has sixinfrared light source intergroups arranged in two rows with threeintergroups in each row. The infrared light source intergroups areconfigured on photobiomodulation therapy headband 22 in a manner whereeach intergroup at least partially overlays or is substantially centeredover sites Fp1 300, Fpz 302, Fp2 304, F3 5306, Fz 308, and F4 310. Theestimated total area of skin surface S and tissue beneath exposed to thenear-infrared light is about 5.3 cm² to about 5.7 cm² and provides aphotobiomodulation therapy to dorsolateral prefrontal cortex (dIPFC) andfrontal eye fields (FEF). Each infrared light source intergroup has nineLEDs in a 3×3 rectangular array. Each LED has about 55 mW of power, withpeak optical output being about 99 mW, and emits infrared light havingan average wavelength of 800 nm to about 850 nm and pulse wave of 40 Hz.The average irradiance over the treatment area is about 16 mW/cm² toabout 20 mW/cm², with areas of maximum irradiance potentially up toabout 240 mW/cm² to about 365 mW/cm². The average fluence over thetreatment area is about 40 J/cm² to about 45 J/cm², with areas ofmaximum fluence potentially up to about 665 J/cm² to about 998 J/cm².The total energy incident during the treatment session is about 2.0 kJto about 2.5 kJ. Controller 200 operates the LEDs continuously (notpulsed) for 10 minutes to 25 minutes.

In an alternative configuration, one or more of the six infrared lightsources intergroup of photobiomodulation therapy headband 22 has acombination of both high-powered and low-powered infrared light sources170. For example, the upper left and upper right infrared light sourceintergroups can have the center infrared light source 170 of the 3×3array be a high-powered infrared light source and the remaining infraredlight sources 170 being low-powered infrared light sources.

In an alternative configuration, photobiomodulation therapy headband 22exhibits an average irradiance over the treatment area is about 31mW/cm² to about 35 mW/cm², with areas of maximum irradiance potentiallyup to about 445 mW/cm² to about 670 mW/cm². In addition, the averagefluence over the treatment area is about 38 J/cm² to about 60 J/cm²,with areas of maximum fluence potentially up to about 665 J/cm² to about1,005 J/cm². The total energy incident during the treatment session isabout 2.0 kJ to about 5.0 kJ.

Example 2 Photobiomodulation Therapy Garment

In another example arrangement of transcranial photobiomodulationtherapy garment 20, specifically photobiomodulation therapy headband 22,has three infrared light source intergroups arranged in one row. Theinfrared light source intergroups are configured on photobiomodulationtherapy headband 22 in a manner where each intergroup at least partiallyoverlays or is substantially centered over sites Fp1 300, Fpz 302, andFp2 304. The estimated total area of skin surface S and tissue beneathexposed to the near-infrared light is about 2.8 cm² to about 3.3 cm² andprovides a photobiomodulation therapy to the frontal eye fields (FEF).Each infrared light source intergroup has nine low powered LEDs in a 3×3rectangular array. Each infrared light source intergroup has nine LEDsin a 3×3 rectangular array. Each LED has about 55 mW of power, with peakoptical output being about 99 mW, and emits infrared light having anaverage wavelength of 800 nm to about 850 nm and pulse wave of 40 Hz(range 0 Hz to 100 Hz). The average irradiance over the treatment areais about 31 mW/cm² to about 35 mW/cm², with areas of maximum irradiancepotentially up to about 80 mW/cm² to about 105 mW/cm². The averagefluence over the treatment area is about 58 J/cm² to about 63 J/cm²,with areas of maximum fluence potentially up to about 145 J/cm² to about185 J/cm². The total energy incident during the treatment session isabout 1.2 kJ to about 3.0 kJ. Controller 200 operates the LEDscontinuously (not pulsed) for 10 minutes to 40 minutes.

In an alternative configuration, controller 200 operates the LEDs in apulsed operation at 40 Hz and 50% duty cycle (variable range being 5% to100%) for 30 minutes to about 40 minutes. Average irradiance, averageareas of maximum irradiance, and average fluence are as described above,with peak irradiance being about 66 mW/cm² to about 67 mW/cm², peakareas of maximum irradiance potentially up to about 160 mW/cm² to about205 mW/cm², and peak fluence over the treatment area maximum fluencebeing potentially up to about 145 J/cm² to about 185 J/cm².

In an alternative configuration, controller 200 operates the LEDs in apulsed operation at 40 Hz and 33% duty cycle (variable range being 5% to100%) for 30 minutes to about 40 minutes. Average irradiance, averageareas of maximum irradiance, and average fluence are as described above,with peak irradiance being about 99 mW/cm² to about 101 mW/cm², peakareas of maximum irradiance potentially up to about 240 mW/cm² to about310 mW/cm², and peak fluence over the treatment area maximum fluencebeing potentially up to about 145 J/cm² to about 185 J/cm². The totalenergy incident during the treatment session is approximately 2.3 kJ.

In an alternative configuration, controller 200 operates the LEDs in apulsed operation at 10 Hz or 40 Hz and 20% duty cycle (variable rangebeing 5% to 100%) for 30 minutes to about 40 minutes. Averageirradiance, average areas of maximum irradiance, and average fluence areas described above, with peak irradiance being about 165 mW/cm² to about167 mW/cm², peak areas of maximum irradiance potentially up to about 405mW/cm² to about 510 mW/cm², and peak fluence over the treatment areamaximum fluence being potentially up to about 145 J/cm² to about 185J/cm². The total energy incident during the treatment session isapproximately 2.3 kJ.

Example 3 Photobiomodulation Therapy Garment

In another example arrangement of transcranial photobiomodulationtherapy garment 20, specifically photobiomodulation therapy headband 22,has six infrared light source intergroups arranged in two rows with fourintergroups in the top row and two intergroups in the row and organizedas two inverse triangles. The infrared light source intergroups areconfigured on photobiomodulation therapy headband 22 in a manner whereone inverse triangle arrangement at least partially overlays or issubstantially centered over sites F3 306, Fz 308, and Fp1 300 and theother inverse triangle arrangement at least partially overlays or issubstantially centered over sites Fz 308, F4 310, and Fp2 304. Theestimated total area of skin surface S and tissue beneath exposed to thenear-infrared light is about 7.5 cm² to about 9 cm² (each inversetriangle arrangement covering about 3.75 cm² to about 4.5 cm²) andprovides a photobiomodulation therapy to the dorsolateral prefrontalcortex (dIPFC). Each infrared light source intergroup has one highpowered LED. Each LED has 500 mW of power, with peak optical outputbeing 500 mW to 1,000 mW, and emits infrared light having an averagewavelength of 800 nm to about 850 nm and pulse wave of between 10 Hz toabout 40 Hz (range of 0 Hz to 5,000 Hz). The average irradiance over thetreatment area is about 50 mW/cm² to about 300 mW/cm², with areas ofmaximum irradiance potentially up to about 500 mW/cm² to about 1,000mW/cm². The average fluence over the treatment area is about 40 J/cm² toabout 120 J/cm², with areas of maximum fluence potentially up to about450 J/cm² to about 1,025 J/cm². The total energy incident during thetreatment session is about 0.4 kJ to about 2.1 kJ. Controller 200operates the LEDs in a pulsed operation at between about 10 Hz and about40 Hz and 20% duty cycle (variable range being 5% to 100%) for 10minutes to about 40 minutes.

In an alternative configuration, each LED has 500 mW of power and emitsinfrared light having an average wavelength of 960 nm to about 1,100 nmand pulse wave of between 0 Hz to about 100 Hz and potentially up to5,000 Hz.

Example 4 Photobiomodulation Therapy Garment

In another example arrangement of transcranial photobiomodulationtherapy garment 20, specifically photobiomodulation therapy headband 22,has five infrared light source intergroups arranged in two rows withthree intergroups in the top row and two intergroups in the bottom rowand organized in a manner where one of each intergroup is located belowone of the outside intergroups from the top row. The infrared lightsource intergroups are configured on photobiomodulation therapy headband22 in a manner where infrared light source intergroups in the top row atleast partially overlays or is substantially centered over sites F3 306,Fz 308, and F4 310, one of the intergroups in the bottom row at leastpartially overlays or is substantially centered over site Fp1 300 andthe other intergroups in the bottom row at least partially overlays oris substantially centered over site Fp2 304. The estimated total area ofskin surface S and tissue beneath exposed to the near-infrared light isabout 7.5 cm² to about 8 cm² and provides a photobiomodulation therapyto the dorsolateral prefrontal cortex (dIPFC) and the frontal eye fields(FEF). Each infrared light source intergroup has one high powered LED.Each LED has 500 mW of power, with peak optical output being 500 mW to1,000 mW, and emits infrared light having an average wavelength of 800nm to about 850 nm and pulse wave of between 10 Hz to about 40 Hz(having an adjustable range of 0 Hz to 5,000 Hz). The average irradianceover the treatment area is about 50 mW/cm² to about 300 mW/cm², withareas of maximum irradiance potentially up to about 500 mW/cm² to about1,000 mW/cm². The average fluence over the treatment area is about 40J/cm² to about 120 J/cm², with areas of maximum fluence potentially upto about 450 J/cm² to about 1,025 J/cm². The total energy incidentduring the treatment session is about 0.4 kJ to about 2.1 kJ. Controller200 operates the LEDs in a pulsed operation at between about 10 Hz andabout 40 Hz and 20% duty cycle (variable range being 5% to 100%) for 10minutes to about 40 minutes.

In an alternative configuration, each LED has 500 mW of power and emitsinfrared light having an average wavelength of 960 nm to about 1,100 nmand pulse wave of between 0 Hz to about 100 Hz and potentially up to5,000 Hz.

Example 5 Photobiomodulation Therapy Garment

In another example arrangement of transcranial photobiomodulationtherapy garment 20, specifically photobiomodulation therapy headband 22,has three infrared light source intergroups arranged in one row. Theinfrared light source intergroups are configured on photobiomodulationtherapy headband 22 in a manner where each intergroup at least partiallyoverlays or is substantially centered over sites F3 306, Fz 308 and F4310. The estimated total area of skin surface S and tissue beneathexposed to the near-infrared light is about 2.8 cm² to about 3.3 cm² andprovides a photobiomodulation therapy to the dorsolateral prefrontalcortex (dIPFC). Each infrared light source intergroup has one highpowered LED. Each LED has 500 mW of power, with peak optical outputbeing 500 mW to 1,000 mW, and emits infrared light having an averagewavelength of 800 nm to about 850 nm and pulse wave of between 10 Hz toabout 40 Hz. The average irradiance over the treatment area is about 50mW/cm² to about 300 mW/cm², with areas of maximum irradiance potentiallyup to about 500 mW/cm² to about 1,000 mW/cm². The average fluence overthe treatment area is about 6 J/cm² to about 12 J/cm², with areas ofmaximum fluence potentially up to about 450 J/cm² to about 1,025 J/cm².The total energy incident during the treatment session is about 0.15 kJto about 1.8 kJ. Controller 200 operates the LEDs in a pulsed operationat between about 10 Hz and about 40 Hz and 20% duty cycle (variablerange being 5% to 100%) for 10 minutes to about 40 minutes.

In an alternative configuration, each LED has 500 mW of power and emitsinfrared light having an average wavelength of 860 nm to about 1,100 nmand pulse wave of between 0 Hz to about 100 Hz and potentially up to5,000 Hz.

Example 6 tPBM Treatment Increases Functional Conductivity of Neurons

A research study was conducted to assess the neuronal conductivityeffects of a transcranial photobiomodulation (tPBM) treatment using aphotobiomodulation therapy garment disclosed herein. Each participantunderwent an EEG analysis for 8 minutes before a tPBM treatment in orderto establish a baseline. Each participant was then administered tPBMtreatments using a photobiomodulation therapy garment disclosed herein.Each tPBM treatment was bilateral and applied to the frontal areas withtwo application sites on the left side, two on the right side and two onthe midline [left, right and center forehead on the frontal EEG sites onF3, Fpl, F4, Fp2 and Fz, Fpz]. Once accurate placement is ensured, atPBM treatment was initiated by a button press on a specific phoneapplication to activate the probes delivering the LED light. Theduration of irradiation was 40 min per treatment. The tPBM treatmentfollowed these specifications: the energy was administered with aradiation wavelength of 850 nm, the irradiance (IR) was 18 mW/cm²; thefluence was up to 43 Joules/cm²; the energy delivered per session was upto 2.4 kJ; and each treatment window area was 55 cm². After completionof the tPBM treatment, each participant underwent a second EEG analysisfor 8 minutes.

The results of this research study showed that participants exhibitingincreased functional connectivity of their neurons (as measured with EEGactivity) compared to sham. For example, FIGS. 17A-C shows the resultsof five (5) participants. Scans of the EEG analysis conducted after thetPPB treatment exhibit focused points of light (FIG. 17B) as compared toscans taken before the tPBM treatment (FIG. 17A). These differences arefurther underscored by FIG. 17C, which illustrates the focused light ofthe before and after scans. These findings is indicative of improvedconnections between neurons. Increased functional connectivity allowneurons to transmit information faster and more accurately. The resultswere reproducible and not evident with the sham.

Example 7 tPBM Treatment Increases Brain Activity

A research study was conducted to assess brain activity effects of atranscranial photobiomodulation (tPBM) treatment using aphotobiomodulation therapy garment disclosed herein. Each participantunderwent an EEG analysis for 8 minutes before a tPBM treatment in orderto establish a baseline. Each participant was then administered tPBMtreatments using a photobiomodulation therapy garment disclosed herein.Each tPBM treatment was bilateral and applied to the frontal areas withtwo application sites on the left side, two on the right side and two onthe midline [left, right and center forehead on the frontal EEG sites onF3, Fpl, F4, Fp2 and Fz, Fpz]. Once accurate placement is ensured, atPBM treatment was initiated by a button press on a specific phoneapplication to activate the probes delivering the LED light. Theduration of irradiation was 40 min per treatment. The tPBM treatmentfollowed these specifications: the energy was administered with aradiation wavelength of 850 nm, the irradiance (IR) was 18 mW/cm²; thefluence was up to 43 Joules/cm²; the energy delivered per session was upto 2.4 kJ; and each treatment window area was 55 cm². After completionof the tPBM treatment, each participant underwent a second EEG analysisfor 8 minutes.

The results of this research study showed that participants exhibitedincreased brain gamma oscillation increased during a 40 Hz pulse wavetherapy compared to sham. For example, FIGS. 18A-18B shows arepresentative result from one participant. As shown in FIG. 18A by theshaded block, there was a significant increase of over 35% in braingamma oscillations at a frequency of 40 Hz. In addition, as shown inFIG. 18B, there is a significant peak of gamma power between about 250seconds to about about 350 seconds, at which point gamma power levelsdecline but are maintained at a higher level as compared to baselinegamma power levels. These findings are indicative of brain gamma wavestimulation which underlie many cognitive operations includingperception. Increased brain gamma wave stimulation promotes brainactivity to transmit information faster and more accurately. The resultswere reproducible and not evident with the sham.

Example 8 tPBM Treatment for Depression in Adults

An 8-week open-label pilot clinical study was conducted to assess thesafety, and efficacy of a tPBM treatment using a photobiomodulationtherapy garment disclosed herein in adults with active depressivesymptoms. The study enrolled 19 participants clinically diagnosed withmoderate to severe depressive symptoms according to the Beck'sDepressive Inventory (BDI, baseline score of 25).

Participants were administered tPBM treatments twice daily at home for 8weeks using a photobiomodulation therapy garment disclosed herein. EachtPBM treatment was bilateral and applied to the frontal areas with twoapplication sites on the left side, two on the right side and two on themidline [left, right and center forehead on the frontal EEG sites on F3,Fpl, F4, Fp2 and Fz, Fpz]. Once accurate placement is ensured, a tPBMtreatment was initiated by a button press on a specific phoneapplication to activate the probes delivering the LED light. Theduration of irradiation was 40 min per treatment. The tPBM treatmentwill follow these specifications: the energy will be administered with aradiation wavelength of 850 nm, the irradiance (IR) will be 18 mW/cm²;the fluence will be up to 43 Joules/cm²; the energy delivered persession will be up to 2.4 kJ; and each treatment window area will be 55cm².

At the end of the 8-week clinical study of tPBM treatment of depressionusing a photobiomodulation therapy garment disclosed herein,investigators detected a significant reduction in depressive symptomsamong participants. For example, participants experienced a 43% decreasein depressive symptoms at week 8 as assessed by the Beck's DepressionInventory. The finding was a statistically significant change frombaseline (significance p=0.001). Interestingly, the improvement wasmaintained for at least 4 weeks after stopping the tPBM treatment. Infact, at week 12 the investigators still detected an average decrease of48% in depressive symptoms, compared to baseline, as assessed by theBeck's Depression Inventory. The finding was also a significant changefrom baseline (significance p<0.0001). Subsequent analyses revealed thatthe improvements in depression were at least partially explained byimprovement in sleep quality.

Example 9 tPBM Treatment for Pediatric Depression

An 8-week open-label pilot clinical study will be conducted to assessthe safety, and efficacy of a tPBM treatment using a photobiomodulationtherapy garment disclosed herein in children with active depressivesymptoms as assessed through the Child Behavior Checklist (CBCL). Thestudy will enroll 20-30 participants, ages 6 to 17 years, who currentlyexperience a CBCL T score of 60 or higher on the Anxious/Depressedscale. Each participant will be clinically assessed by completing aseries of clinical intake questionnaires and scales, including 1) CBCL,a parent-report questionnaire that evaluates maladaptive behavioral andemotional problems, both internalizing and externalizing, in childrenages 6-18; 2) the Pediatric Quality Of Life Enjoyment and SatisfactionQuestionnaire (PQ-LES-Q), a 15 question parent-report form designed tohelp assess the degree of enjoyment and satisfaction the child isexperiencing during the past week; 3) the Behavior Rating Inventory ofExecutive Function-Parent Report (BRIEF-P), a 78-item rating scale toassess level of executive function deficits; and 4) the SocialResponsiveness Scale (SRS), a 65-item rating scale completed by theparent used to measure social deficits as they occur in naturalsettings.

Participants will be administered daily tPBM treatments for 8 weeks.tPBM treatment will use a photobiomodulation therapy garment disclosedherein will be bilateral and applied to the frontal areas with twoapplication sites on the left side, two on the right side and two on themidline [left, right and center forehead on the frontal EEG sites on F3,Fpl, F4, Fp2 and Fz, Fpz]. Once accurate placement is ensured, a tPBMtreatment will be initiated by a button press on a specific phoneapplication to activate the probes delivering the LED light. Theduration of irradiation will start at 10 min per treatment for the firstweek (days 1-7), increase to 20 min per treatment during the second weekof treatment (days 7-14) and to 30 min per treatment at week 3 (days14-21) of treatment. If side-effects prevent increase (or if treatmentresponse already occurred), a lower dose will be kept in order to ensuregood tolerability and treatment adherence. At day 21, the clinician willrecommend 40 min daily treatment if no improvement in the context ofgood tolerability. The tPBM treatment will follow these specifications:the energy will be administered with a radiation wavelength of 850 nm,the irradiance (IR) will be 18 mW/cm²; the fluence will be up to 43Joules/cm²; the energy delivered per session will be up to 2.4 kJ; andeach treatment window area will be 55 cm².

Subjects will be evaluated at weekly intervals for the first four weeks,and biweekly thereafter. At each visit, measures of safety and efficacywill be obtained using assessments of psychiatric symptoms andfunctioning and measures of adverse effects. At the midpoint (end ofweek 4) and final study visits (week 8 or Endpoint), additionalclinician- and subject-rated assessments will be completed. Response totreatment will be assessed by the following assessment measures 1) aClinician completed Depression Specific Clinical Global Impression(CGI-Depression), including Clinical Global Severity (CGI-S), ClinicalGlobal Improvement (CGI-I), and the CGI-Efficacy Index (CGI-EI) Scale,will be completed by the physician at every visit; 2) an AffectiveReactivity Index-Parent Report (ARI-P), a concise, 7 questionparent-report form assessing irritability and temper, will be completedby the parent at week 0 (baseline), week 4 and week 8; 3) a ChildhoodAnxiety Sensitivity Index (CASI-Anx), a 38-item scale that assessessymptoms of anxiety, will be completed by the parent at week 0(baseline), week 4 and week 8; and 4) a Children's Depression Inventory(CDI), a 27-item scale that assesses symptoms of depression, will becompleted by the parent at week 0 (baseline), week 4 and week 8.

The results are expected to show that a tPBM treatment will be safe andeffective in reducing symptoms of pediatric depression.

Example 10 tPBM Treatment of Autistic Traits in Children with AttentionDeficit Hyperactivity Disorder (ADHD)

A 10-week open-label pilot clinical study will be conducted to assessthe tolerability, safety, and efficacy of a tPBM treatment using aphotobiomodulation therapy garment disclosed herein in childrendiagnosed with ADHD who also present with at least moderate level ofautistic traits. The study will enroll 90-100 participants, ages 9 to 17years, who fulfill the DSM-5 diagnostic criteria for ADHD and presentwith moderately severe autistic spectrum disorder symptoms asestablished by a Social Responsiveness Scale, 2^(nd) Edition (SRS-2) rawscore of 75 or higher or a Clinical Global Impressions—Autistic Traits(CGI-AT) severity score of 4 or higher. Each participant will beclinically assessed by a board-certified clinician for ADHD and autismtraits and all participant's parent/guardian will be administered anassessment battery including a brief demographic interview and theAutism Trait Specific Clinical Global Impression (CGI-AT), includingClinical Global Severity (CGI-S), Clinical Global Improvement (CGI-I),and the CGI-Efficacy Index (CGI-EI) Scale, the Behavior Rating Inventoryof Executive Function-Parent Version (BRIEF-P), the Child BehaviorChecklist (CBCL), the Clinician-Rated Treatment Emergent Adverse EventsLog (CTAE), the Global Assessment of Functioning Scale (GAF), theMassachusetts General Hospital Social-Emotional Competence Scale(MGH-SECS) questionaries including MGH-SECS-Informant Rated (MGH-SECS-I)and MGH-SECS Clinician Rated (MGH-SECS-C), the MGH Autism SpectrumDisorder DSM-5 Diagnostic Symptom Checklist (MGH-ASD-SCL), and the SRR-2questionnaires.

Participants will be administered daily tPBM treatments for 8 weeks anda post-study follow-up will occur at week 10. tPBM treatment will use aphotobiomodulation therapy garment disclosed herein will be bilateraland applied to the frontal areas with two application sites on the leftside, two on the right side and two on the midline [left, right andcenter forehead on the frontal EEG sites on F3, Fpl, F4, Fp2 and Fz,Fpz]. Once accurate placement is ensured, a tPBM treatment will beinitiated by a button press on a specific phone application to activatethe probes delivering the LED light. The duration of irradiation willstart at 10 min per treatment for the first week (days 1-7), increase to20 min per treatment during the second week of treatment (days 7-14) andto 30 min per treatment at week 3 (days 14-21) of treatment. Ifside-effects prevent increase (or if treatment response alreadyoccurred), a lower dose will be kept in order to ensure goodtolerability and treatment adherence. At day 21, the clinician willrecommend 40 min daily treatment if no improvement in the context ofgood tolerability. The tPBM treatment will follow these specifications:the energy will be administered with a radiation wavelength of 850 nm,the irradiance (IR) will be 18 mW/cm²; the fluence will be up to 43Joules/cm²; the energy delivered per session will be up to 2.4 kJ; andeach treatment window area will be 55 cm².

Subjects will be evaluated at weekly intervals for the first four weeks,and biweekly thereafter. At each visit, measures of safety and efficacywill be obtained using assessments of psychiatric symptoms andfunctioning and measures of adverse effects. At the midpoint (end ofweek 4) and final study visits (week 8 or Endpoint), additionalclinician- and subject-rated assessments will be completed. Response totreatment will be assessed by the following assessment measures 1) anCGI-AT, including CGI-S, CGI-I, and CGI-EI Scale, will be completed bythe physician at weeks 0 (baseline), 1, 2, 3, 4, 6, and 8; 2) a GAF andCTAE will be completed by the physician at weeks 0 (baseline), 1, 2, 3,4, 6, and 8; 3) an Attention Deficit Hyperactivity Disorder SymptomChecklist (ADHD-SC) will be completed by the physician at weeks 0(baseline), 4, and 8; 4) a tPBM Self-Report Questionnaire (TSRQ) will becompleted by the parent/guardian at weeks 1, 2, 3, 4, 6, and 8; 5) aSRS-2 and CBCL will be completed by the physician at weeks 4 and 8; 5) aBRIEF-P and MGH-SECS-I will be completed by the parent/guardian at week8; and 6) a MGH-SECS-C will be completed by the physician at week 8. Atweek 10, each participant will be assessed by CGI-AT, including CGI-S,CGI-I, and CGI-EI Scale, GAF, CTAE, SRS-1, ADHD-SC, and TSRQ,

The results are expected to show that a tPBM treatment will be safe andeffective in reducing autistic traits in children diagnosed with ADHD.

In closing, foregoing descriptions of embodiments of the presentinvention have been presented for the purposes of illustration anddescription. It is to be understood that, although aspects of thepresent invention are highlighted by referring to specific embodiments,one skilled in the art will readily appreciate that these describedembodiments are only illustrative of the principles comprising thepresent invention. As such, the specific embodiments are not intended tobe exhaustive or to limit the invention to the precise forms disclosed.Therefore, it should be understood that embodiments of the disclosedsubject matter are in no way limited to a particular element, compound,composition, component, article, apparatus, methodology, use, protocol,step, and/or limitation described herein, unless expressly stated assuch.

In addition, groupings of alternative embodiments, elements, stepsand/or limitations of the present invention are not to be construed aslimitations. Each such grouping may be referred to and claimedindividually or in any combination with other groupings disclosedherein. It is anticipated that one or more alternative embodiments,elements, steps and/or limitations of a grouping may be included in, ordeleted from, the grouping for reasons of convenience and/orpatentability. When any such inclusion or deletion occurs, thespecification is deemed to contain the grouping as modified, thusfulfilling the written description of all Markush groups used in theappended claims.

Furthermore, those of ordinary skill in the art will recognize thatcertain changes, modifications, permutations, alterations, additions,subtractions and sub-combinations thereof can be made in accordance withthe teachings herein without departing from the spirit of the presentinvention. Furthermore, it is intended that the following appendedclaims and claims hereafter introduced are interpreted to include allsuch changes, modifications, permutations, alterations, additions,subtractions and sub-combinations as are within their true spirit andscope. Accordingly, the scope of the present invention is not to belimited to that precisely as shown and described by this specification.

Certain embodiments of the present invention are described herein,including the best mode known to the inventors for carrying out theinvention. Of course, variations on these described embodiments willbecome apparent to those of ordinary skill in the art upon reading theforegoing description. The inventor expects skilled artisans to employsuch variations as appropriate, and the inventors intend for the presentinvention to be practiced otherwise than specifically described herein.Accordingly, this invention includes all modifications and equivalentsof the subject matter recited in the claims appended hereto as permittedby applicable law. Moreover, any combination of the above-describedembodiments in all possible variations thereof is encompassed by theinvention unless otherwise indicated herein or otherwise clearlycontradicted by context.

The words, language, and terminology used in this specification is forthe purpose of describing particular embodiments, elements, steps and/orlimitations only and is not intended to limit the scope of the presentinvention, which is defined solely by the claims. In addition, suchwords, language, and terminology are to be understood not only in thesense of their commonly defined meanings, but to include by specialdefinition in this specification structure, material or acts beyond thescope of the commonly defined meanings. Thus, if an element, step orlimitation can be understood in the context of this specification asincluding more than one meaning, then its use in a claim must beunderstood as being generic to all possible meanings supported by thespecification and by the word itself.

The definitions and meanings of the elements, steps or limitationsrecited in a claim set forth below are, therefore, defined in thisspecification to include not only the combination of elements, steps orlimitations which are literally set forth, but all equivalent structure,material or acts for performing substantially the same function insubstantially the same way to obtain substantially the same result. Inthis sense it is therefore contemplated that an equivalent substitutionof two or more elements, steps or limitations may be made for any one ofthe elements, steps or limitations in a claim set forth below or that asingle element, step or limitation may be substituted for two or moreelements, steps or limitations in such a claim. Although elements, stepsor limitations may be described above as acting in certain combinationsand even initially claimed as such, it is to be expressly understoodthat one or more elements, steps or limitations from a claimedcombination can in some cases be excised from the combination and thatthe claimed combination may be directed to a sub-combination orvariation of a sub-combination. As such, notwithstanding the fact thatthe elements, steps and/or limitations of a claim are set forth below ina certain combination, it must be expressly understood that theinvention includes other combinations of fewer, more or differentelements, steps and/or limitations, which are disclosed in above evenwhen not initially claimed in such combinations. Furthermore,insubstantial changes from the claimed subject matter as viewed by aperson with ordinary skill in the art, now known or later devised, areexpressly contemplated as being equivalently within the scope of theclaims. Therefore, obvious substitutions now or later known to one withordinary skill in the art are defined to be within the scope of thedefined elements. Accordingly, the claims are thus to be understood toinclude what is specifically illustrated and described above, what isconceptually equivalent, what can be obviously substituted and also whatessentially incorporates the essential idea of the invention.

Unless otherwise indicated, all numbers expressing a characteristic,item, quantity, parameter, property, term, and so forth used in thepresent specification and claims are to be understood as being modifiedin all instances by the term “about.” As used herein, the term “about”means that the characteristic, item, quantity, parameter, property, orterm so qualified encompasses a range of plus or minus ten percent aboveand below the value of the stated characteristic, item, quantity,parameter, property, or term. Accordingly, unless indicated to thecontrary, the numerical parameters set forth in the specification andattached claims are approximations that may vary. For instance, as massspectrometry instruments can vary slightly in determining the mass of agiven analyte, the term “about” in the context of the mass of an ion orthe mass/charge ratio of an ion refers to +/−0.50 atomic mass unit. Atthe very least, and not as an attempt to limit the application of thedoctrine of equivalents to the scope of the claims, each numericalindication should at least be construed in light of the number ofreported significant digits and by applying ordinary roundingtechniques.

Notwithstanding that the numerical ranges and values setting forth thebroad scope of the invention are approximations, the numerical rangesand values set forth in the specific examples are reported as preciselyas possible. Any numerical range or value, however, inherently containscertain errors necessarily resulting from the standard deviation foundin their respective testing measurements. Recitation of numerical rangesof values herein is merely intended to serve as a shorthand method ofreferring individually to each separate numerical value falling withinthe range. Unless otherwise indicated herein, each individual value of anumerical range is incorporated into the present specification as if itwere individually recited herein.

Use of the terms “may” or “can” in reference to an embodiment or aspectof an embodiment also carries with it the alternative meaning of “maynot” or “cannot.” As such, if the present specification discloses thatan embodiment or an aspect of an embodiment may be or can be included aspart of the inventive subject matter, then the negative limitation orexclusionary proviso is also explicitly meant, meaning that anembodiment or an aspect of an embodiment may not be or cannot beincluded as part of the inventive subject matter. In a similar manner,use of the term “optionally” in reference to an embodiment or aspect ofan embodiment means that such embodiment or aspect of the embodiment maybe included as part of the inventive subject matter or may not beincluded as part of the inventive subject matter. Whether such anegative limitation or exclusionary proviso applies will be based onwhether the negative limitation or exclusionary proviso is recited inthe claimed subject matter.

The terms “a,” “an,” “the” and similar references used in the context ofdescribing the present invention (especially in the context of thefollowing claims) are to be construed to cover both the singular and theplural, unless otherwise indicated herein or clearly contradicted bycontext. Further, ordinal indicators—such as, e.g., “first,” “second,”“third,” etc.—for identified elements are used to distinguish betweenthe elements, and do not indicate or imply a required or limited numberof such elements, and do not indicate a particular position or order ofsuch elements unless otherwise specifically stated. All methodsdescribed herein can be performed in any suitable order unless otherwiseindicated herein or otherwise clearly contradicted by context. The useof any and all examples or exemplary language (e.g., “such as”) providedherein is intended merely to better illuminate the present invention anddoes not pose a limitation on the scope of the invention otherwiseclaimed. No language in the present specification should be construed asindicating any non-claimed element essential to the practice of theinvention.

When used in the claims, whether as filed or added per amendment, theopen-ended transitional term “comprising”, variations thereof such as,e.g., “comprise” and “comprises”, and equivalent open-ended transitionalphrases thereof like “including,” “containing” and “having”, encompassall the expressly recited elements, limitations, steps, integers, and/orfeatures alone or in combination with unrecited subject matter; thenamed elements, limitations, steps, integers, and/or features areessential, but other unnamed elements, limitations, steps, integers,and/or features may be added and still form a construct within the scopeof the claim. Specific embodiments disclosed herein may be furtherlimited in the claims using the closed-ended transitional phrases“consisting of” or “consisting essentially of” (or variations thereofsuch as, e.g., “consist of”, “consists of”, “consist essentially of”,and “consists essentially of”) in lieu of or as an amendment for“comprising.” When used in the claims, whether as filed or added peramendment, the closed-ended transitional phrase “consisting of” excludesany element, limitation, step, integer, or feature not expressly recitedin the claims. The closed-ended transitional phrase “consistingessentially of” limits the scope of a claim to the expressly recitedelements, limitations, steps, integers, and/or features and any otherelements, limitations, steps, integers, and/or features that do notmaterially affect the basic and novel characteristic(s) of the claimedsubject matter. Thus, the meaning of the open-ended transitional phrase“comprising” is being defined as encompassing all the specificallyrecited elements, limitations, steps and/or features as well as anyoptional, additional unspecified ones. The meaning of the closed-endedtransitional phrase “consisting of” is being defined as only includingthose elements, limitations, steps, integers, and/or featuresspecifically recited in the claim, whereas the meaning of theclosed-ended transitional phrase “consisting essentially of” is beingdefined as only including those elements, limitations, steps, integers,and/or features specifically recited in the claim and those elements,limitations, steps, integers, and/or features that do not materiallyaffect the basic and novel characteristic(s) of the claimed subjectmatter. Therefore, the open-ended transitional phrase “comprising” (andequivalent open-ended transitional phrases thereof) includes within itsmeaning, as a limiting case, claimed subject matter specified by theclosed-ended transitional phrases “consisting of” or “consistingessentially of.” As such, the embodiments described herein or so claimedwith the phrase “comprising” expressly and unambiguously providedescription, enablement, and support for the phrases “consistingessentially of” and “consisting of.”

Lastly, all patents, patent publications, and other references cited andidentified in the present specification are individually and expresslyincorporated herein by reference in their entirety for the purpose ofdescribing and disclosing, for example, the compositions andmethodologies described in such publications that might be used inconnection with the present invention. These publications are providedsolely for their disclosure prior to the filing date of the presentapplication. Nothing in this regard is or should be construed as anadmission that the inventors are not entitled to antedate suchdisclosure by virtue of prior invention or for any other reason. Allstatements as to the date or representation as to the contents of thesedocuments are based on the information available to the applicant and donot constitute any admission as to the correctness of the dates orcontents of these documents.

1. A photobiomodulation therapy garment comprising: a garment configuredto be donned by a user atop a skin surface, the garment comprising afirst surface and a second surface opposite the first surface, the firstsurface being configured to face the skin surface once the garment isdonned, and a photobiomodulation unit integrated within the garment, thephotobiomodulation unit comprising a connection terminal, one or morenear-infrared light sources, and one or more sensors, the connectionterminal in electronic communication with the one or more near-infraredlight sources and one or more sensors, wherein the one or morenear-infrared light sources are each configured to emit near-infraredlight at a wavelength between 600 nm to 1600 nm and at a predetermineddosimetry, a controller, the controller including a processor and amemory, the controller configured to operationally engage a terminalrail of the connection terminal in an manner that establishes electroniccommunication between the controller and the connection terminal;wherein the first surface of the garment includes a first portioncomprising one or more light openings, with each of the one or morenear-infrared light sources being in operational alignment with the oneor more light openings to permit proper passage of near-infrared lightfrom the one or more near-infrared light sources therethrough, whereinthe first surface of the garment includes a second portion comprisingone or more sensor openings with each of the one or more sensors beingin operational alignment with the one or more sensor openings to permitproper functionality of the one or more sensors therethrough, andwherein the processor and the memory are configured with executableinstructions for independently controlling each of the one or morenear-infrared light sources and each of each of the one or more sensors.2. The photobiomodulation therapy garment of claim 1, wherein thegarment is configured to wrap about or conform to a body part region,with the capability to be moved from one body part region to anotherbody part region on the body.
 3. The photobiomodulation therapy garmentof claim 1, wherein the garment is sized and dimensioned to specificallyfit a particular body part.
 4. The photobiomodulation therapy garment ofclaim 1, wherein each of the one or more near-infrared light sources isa near-infrared light emitting diode.
 5. The photobiomodulation therapygarment of claim 1, wherein each of the one or more sensors isconfigured to detect and collect information on one or more parametersof the garment, the photobiomodulation unit and components therein, thecontroller and components therein, and the user, and thereafter transmitthe information to the controller.
 6. The photobiomodulation therapygarment of claim 5, wherein the one or more parameters includesoperational information of the garment, the photobiomodulation unit andcomponents therein, and the controller and components therein, biometricinformation on the user, or any combination thereof.
 7. Thephotobiomodulation therapy garment of claim 1, wherein the executableinstructions independently control each of the one or more near-infraredlight sources.
 8. The photobiomodulation therapy garment of claim 7,wherein the executable instructions control activation, duration ofactivation, deactivation, duration of deactivation, a pattern and timingof activation, a pattern and timing of deactivation, a fluence level, anirradiance level, a dosimetry level, a pulsed operation, a continuousoperation, an operation time, a cycle duration, or any combinationthereof for each of the one or more near-infrared light sources.
 9. Thephotobiomodulation therapy garment of claim 1, wherein the executableinstructions independently control each of the one or more sensors. 10.The photobiomodulation therapy garment of claim 9, wherein theexecutable instructions control collection and analysis of theinformation of each of the one or more sensors.
 11. Thephotobiomodulation therapy garment of claim 1, wherein the one or morenear-infrared light sources are a plurality of spaced apartnear-infrared light sources.
 12. The photobiomodulation therapy garmentof claim 11, wherein the plurality of near-infrared light sources arearranged in a plurality of spaced apart near-infrared light sourcegroups, each of the plurality of near-infrared light source groupscomprising a plurality of near-infrared light sources.
 13. Thephotobiomodulation therapy garment of claim 1 further comprising one ormore stimulators.
 14. The photobiomodulation therapy garment of claim13, wherein the one or more stimulators include a component that cangenerate a magnetic field.
 15. The photobiomodulation therapy garment ofclaim 1, wherein the processor and the memory are configured withexecutable instructions for dynamically controlling each of the one ormore near-infrared light sources and each of each of the one or moresensors.
 16. The photobiomodulation therapy garment of claim 1, whereinthe skin surface comprises a forehead site, a posterior cervical site, acarpal site, an abdominal site, or any combination thereof.
 17. Thephotobiomodulation therapy garment of claim 16, wherein the foreheadsite comprises a dorsolateral prefrontal cortex region, a frontal eyefields region, or both.
 18. The photobiomodulation therapy garment ofclaim 16, wherein the forehead site comprises an Fp1 site, an Fpz site,an Fp2 site, an F3 site, an Fz site, an F4 site, or any combinationthereof.